| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| BXB | Exerciser, Powered | 第 1 类 | 21 CFR 890.5380 | 160 |
| EGJ | Device, Iontophoresis, Other Uses | 第 2 类 | 21 CFR 890.5525 | 73 |
| HPH | Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Hea | 第 3 类 | 21 CFR 890.5275 | |
| IKD | Cable, Electrode | 第 2 类 | 21 CFR 890.1175 | 6 |
| IKE | Transducer, Miniature Pressure | 第 1 类 | 21 CFR 890.1615 | 15 |
| IKK | System, Isokinetic Testing And Evaluation | 第 2 类 | 21 CFR 890.1925 | 61 |
| IKN | Electromyograph, Diagnostic | 第 2 类 | 21 CFR 890.1375 | 75 |
| IKO | Hammer, Reflex, Powered | 第 2 类 | 21 CFR 890.1450 | 1 |
| IKP | Chronaximeter | 第 2 类 | 21 CFR 890.1225 | |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 第 2 类 | 21 CFR 890.1385 | 43 |
| IKW | Utensil, Homemaking | 第 1 类 | 21 CFR 890.5050 | 12 |
| IKX | Aid, Transfer | 第 1 类 | 21 CFR 890.5050 | 18 |
| IKZ | Bed, Patient Rotation, Powered | 第 2 类 | 21 CFR 890.5225 | 17 |
| ILC | Utensil, Eating | 第 1 类 | 21 CFR 890.5050 | 32 |
| ILD | Adaptor, Dressing | 第 1 类 | 21 CFR 890.5050 | 14 |
| ILE | Sling, Arm, Overhead Supported | 第 1 类 | 21 CFR 890.3475 | 3 |
| ILG | Stocking, Elastic | 第 1 类 | 21 CFR 890.3475 | 8 |
| ILH | Splint, Hand, And Components | 第 1 类 | 21 CFR 890.3475 | 36 |
| ILI | Sling, Arm | 第 1 类 | 21 CFR 890.3640 | 21 |
| ILJ | Bath, Hydro-Massage | 第 2 类 | 21 CFR 890.5100 | 73 |
| ILK | Transport, Patient, Powered | 第 2 类 | 21 CFR 890.5150 | 36 |
| ILM | Bath, Sitz, Powered | 第 2 类 | 21 CFR 890.5100 | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | 第 2 类 | 21 CFR 890.5720 | 93 |
| ILP | System, Communication, Non-Powered | 第 1 类 | 21 CFR 890.3700 | 21 |
| ILQ | System, Communication, Powered | 第 2 类 | 21 CFR 890.3710 | 38 |
| ILS | Adaptor, Hygiene | 第 1 类 | 21 CFR 890.5050 | 31 |
| ILT | Adaptor, Recreational | 第 1 类 | 21 CFR 890.5050 | 7 |
| ILW | Adaptor, Grooming | 第 1 类 | 21 CFR 890.5050 | 7 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Hea | 第 2 类 | 21 CFR 890.5290 | 15 |
| ILY | Lamp, Infrared, Therapeutic Heating | 第 2 类 | 21 CFR 890.5500 | 229 |
| ILZ | Accessories, Traction | 第 1 类 | 21 CFR 890.5925 | 15 |
| IMA | Pack, Heat, Moist | 第 1 类 | 21 CFR 890.5730 | 8 |
| IMB | Cabinet, Moist Steam | 第 2 类 | 21 CFR 890.5250 | 5 |
| IMC | Bath, Paraffin | 第 2 类 | 21 CFR 890.5110 | 12 |
| IMD | Pack, Hot Or Cold, Disposable | 第 1 类 | 21 CFR 890.5710 | 82 |
| IME | Pack, Hot Or Cold, Reusable | 第 1 类 | 21 CFR 890.5700 | 27 |
| IMF | Unit, Chilling | 第 1 类 | 21 CFR 890.5940 | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Dee | 第 2 类 | 21 CFR 890.5860 | 55 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 第 2 类 | 21 CFR 890.5300 | 89 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 第 2 类 | 21 CFR 890.5290 | 45 |
| IMK | Wheelchair, Stair Climbing | 第 2 类 | 21 CFR 890.3890 | 3 |
| IML | Armrest, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMM | Footrest, Wheelchair | 第 1 类 | 21 CFR 890.3920 | 2 |
| IMN | Climber, Curb, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMO | Handrim, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMP | Cushion, Wheelchair | 第 1 类 | 21 CFR 890.3920 | 2 |
| IMQ | Attachment, Narrowing, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMR | Device, Anti-Tip, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMS | Support, Head And Trunk, Wheelchair | 第 1 类 | 21 CFR 890.3910 | |
| IMW | Brake, Extension, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| IMX | Board, Lap, Wheelchair | 第 1 类 | 21 CFR 890.3910 | 2 |
| IMY | Armboard, Wheelchair | 第 1 类 | 21 CFR 890.3910 | |
| IMZ | Holder, Crutch And Cane, Wheelchair | 第 1 类 | 21 CFR 890.3910 | |
| INA | Hill Holder, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| INB | Attachment, Commode, Wheelchair | 第 1 类 | 21 CFR 890.3920 | |
| INC | Cuff, Pusher, Wheelchair | 第 1 类 | 21 CFR 890.3910 | |
| INE | Sling, Overhead Suspension, Wheelchair | 第 1 类 | 21 CFR 890.3910 | 1 |
| INF | Scale, Platform, Wheelchair | 第 1 类 | 21 CFR 890.3940 | 5 |
| ING | Elevator, Wheelchair, Portable | 第 2 类 | 21 CFR 890.3930 | 29 |
| INI | Vehicle, Motorized 3-Wheeled | 第 2 类 | 21 CFR 890.3800 | 351 |
| INK | Stretcher, Wheeled, Powered | 第 2 类 | 21 CFR 890.3690 | 12 |
| INM | Chair, With Casters | 第 1 类 | 21 CFR 890.3100 | 35 |
| INN | Chair, Adjustable, Mechanical | 第 1 类 | 21 CFR 890.3100 | 26 |
| INO | Chair, Positioning, Electric | 第 2 类 | 21 CFR 890.3110 | 53 |
| INP | Tips And Pads, Cane, Crutch And Walker | 第 1 类 | 21 CFR 890.3790 | 8 |
| INQ | Table, Powered | 第 1 类 | 21 CFR 890.3760 | 102 |
| INT | Plinth | 第 1 类 | 21 CFR 890.3520 | 4 |
| INW | Table, Mechanical | 第 1 类 | 21 CFR 890.3750 | 35 |
| INX | Bed, Air Fluidized | 第 2 类 | 21 CFR 890.5160 | 28 |
| INY | Bed, Patient Rotation, Manual | 第 1 类 | 21 CFR 890.5180 | 1 |
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | 第 2 类 | 21 CFR 890.5275 | 4 |
| IOB | Lamp, Infrared, Non Heating | 第 2 类 | 21 CFR 890.5500 | 6 |
| IOD | Components, Exercise | 第 1 类 | 21 CFR 890.5350 | 11 |
| IOE | Bars, Parallel, Exercise | 第 1 类 | 21 CFR 890.5370 | 2 |
| IOG | Treadmill, Mechanical | 第 1 类 | 21 CFR 890.5370 | 3 |
| IOL | Treadmill, Powered | 第 1 类 | 21 CFR 890.5380 | 43 |
| ION | Exerciser, Non-Measuring | 第 1 类 | 21 CFR 890.5370 | 43 |
| IOQ | Bed, Flotation Therapy, Powered | 第 2 类 | 21 CFR 890.5170 | 57 |
| IOR | Wheelchair, Mechanical | 第 1 类 | 21 CFR 890.3850 | 463 |
| IOY | Support, Arm | 第 1 类 | 21 CFR 890.3475 | 1 |
| IOZ | Splint, Abduction, Congenital Hip Dislocation | 第 1 类 | 21 CFR 890.3665 | 4 |
| IPF | Stimulator, Muscle, Powered | 第 2 类 | 21 CFR 890.5850 | 548 |
| IPG | Shoe, Cast | 第 1 类 | 21 CFR 890.3025 | 6 |
| IPL | Wheelchair, Standup | 第 2 类 | 21 CFR 890.3900 | 66 |
| IPM | Cover, Limb | 第 1 类 | 21 CFR 890.3025 | 6 |
| IPO | Orthosis, Pneumatic Structure, Rigid | 第 3 类 | 21 CFR 890.3610 | |
| IPR | Crutch | 第 1 类 | 21 CFR 890.3150 | 4 |
| IPS | Cane | 第 1 类 | 21 CFR 890.3075 | 9 |
| IPT | Orthosis, Thoracic | 第 1 类 | 21 CFR 890.3490 | 5 |
| IPW | Orthosis, Sacroiliac, Soft | 第 1 类 | 21 CFR 890.3490 | 1 |
| IPX | Orthosis, Rib Fracture, Soft | 第 1 类 | 21 CFR 890.3490 | 3 |
| IPY | Orthosis, Lumbo-Sacral | 第 1 类 | 21 CFR 890.3490 | 11 |
| IQA | System, Environmental Control, Powered | 第 2 类 | 21 CFR 890.3725 | 24 |
| IQB | Belt, Wheelchair | 第 1 类 | 21 CFR 890.3920 | 2 |
| IQC | Wheelchair, Special Grade | 第 2 类 | 21 CFR 890.3880 | 24 |
| IQE | Orthosis, Lumbar | 第 1 类 | 21 CFR 890.3490 | 4 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | 第 1 类 | 21 CFR 890.3490 | 7 |
| IQG | Adaptor, Holder, Syringe | 第 1 类 | 21 CFR 890.5050 | 3 |
| IQI | Orthosis, Limb Brace | 第 1 类 | 21 CFR 890.3475 | 52 |
| IQJ | Splint, Clavicle | 第 1 类 | 21 CFR 890.3490 | 4 |
| IQK | Orthosis, Cervical | 第 1 类 | 21 CFR 890.3490 | 27 |
| IQM | Splint, Temporary Training | 第 1 类 | 21 CFR 890.3025 | 3 |
| IQO | Device, Prosthesis Alignment | 第 1 类 | 21 CFR 890.3025 | |
| IQP | Rotator, Transverse | 第 1 类 | 21 CFR 890.3025 | 1 |
| IQQ | Joint, Shoulder, External Limb Component | 第 1 类 | 21 CFR 890.3420 | |
| IQW | Hook, External Limb Component, Powered | 第 1 类 | 21 CFR 890.3420 | |
| IQX | Hook, External Limb Component, Mechanical | 第 1 类 | 21 CFR 890.3420 | 1 |
| IQZ | Hand, External Limb Component, Powered | 第 1 类 | 21 CFR 890.3420 | |
| IRA | Hand, External Limb Component, Mechanical | 第 1 类 | 21 CFR 890.3420 | 2 |
| IRD | Joint, Elbow, External Limb Component, Mechanical | 第 1 类 | 21 CFR 890.3420 | |
| IRE | Joint, Elbow, External Limb Component, Powered | 第 1 类 | 21 CFR 890.3420 | 2 |
| IRN | Device, Warning, Overload, External Limb, Powered | 第 2 类 | 21 CFR 890.5575 | 11 |
| IRO | Vibrator, Therapeutic | 第 1 类 | 21 CFR 890.5975 | 65 |
| IRP | Massager, Powered Inflatable Tube | 第 2 类 | 21 CFR 890.5650 | 156 |
| IRQ | Unit, Heating, Powered | 第 1 类 | 21 CFR 890.5950 | 7 |
| IRR | Bars, Parallel, Powered | 第 1 类 | 21 CFR 890.5380 | 1 |
| IRS | Head Halter, Traction | 第 1 类 | 21 CFR 890.5925 | 1 |
| IRT | Pad, Heating, Powered | 第 2 类 | 21 CFR 890.5740 | 42 |
| ISA | Massager, Therapeutic, Electric | 第 1 类 | 21 CFR 890.5660 | 100 |
| ISB | Stimulator, Muscle, Diagnostic | 第 2 类 | 21 CFR 890.1850 | 5 |
| ISD | Exerciser, Measuring | 第 2 类 | 21 CFR 890.5360 | 61 |
| ISH | Component, External, Limb, Ankle/Foot | 第 1 类 | 21 CFR 890.3420 | 4 |
| ISL | Joint, Hip, External Limb Component | 第 1 类 | 21 CFR 890.3420 | |
| ISM | Pylon, Post Surgical | 第 1 类 | 21 CFR 890.3025 | |
| ISN | Cable | 第 1 类 | 21 CFR 890.3420 | |
| ISP | Valve, Prosthesis | 第 1 类 | 21 CFR 890.3420 | 1 |
| ISR | Band Or Belt, Pelvic Support | 第 1 类 | 21 CFR 890.3025 | 1 |
| ISS | Prosthesis, Thigh Socket, External Component | 第 1 类 | 21 CFR 890.3420 | 1 |
| ISW | Assembly, Knee/Shank/Ankle/Foot, External | 第 2 类 | 21 CFR 890.3500 | 1 |
| ISY | Joint, Knee, External Limb Component | 第 1 类 | 21 CFR 890.3420 | 1 |
| ISZ | Unit, Wrist, External Limb Component, Mechanical | 第 1 类 | 21 CFR 890.3420 | |
| ITC | Stirrup, External Brace Component | 第 1 类 | 21 CFR 890.3410 | |
| ITG | Bandage, Cast | 第 1 类 | 21 CFR 890.3025 | 37 |
| ITH | Equipment, Traction, Powered | 第 2 类 | 21 CFR 890.5900 | 71 |
| ITI | Wheelchair, Powered | 第 2 类 | 21 CFR 890.3860 | 586 |
| ITJ | Walker, Mechanical | 第 1 类 | 21 CFR 890.3825 | 14 |
| ITM | Cage, Knee | 第 1 类 | 21 CFR 890.3475 | 5 |
| ITN | Splint, Denis Brown | 第 1 类 | 21 CFR 890.3675 | 3 |
| ITO | Twister, Brace Setting | 第 1 类 | 21 CFR 890.3410 | 1 |
| ITQ | Joint, Knee, External Brace | 第 1 类 | 21 CFR 890.3475 | 15 |
| ITS | Joint, Hip, External Brace | 第 1 类 | 21 CFR 890.3475 | 1 |
| ITW | Joint, Ankle, External Brace | 第 1 类 | 21 CFR 890.3475 | 1 |
| JFA | Exerciser, Finger, Powered | 第 1 类 | 21 CFR 890.5410 | 12 |
| JFB | Table, Physical Therapy, Multi Function | 第 2 类 | 21 CFR 890.5880 | 66 |
| JFC | System, Pressure Measurement, Intermittent | 第 1 类 | 21 CFR 890.1600 | 11 |
| KFT | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | 第 1 类 | 21 CFR 890.3420 | |
| KFW | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered | 第 1 类 | 21 CFR 890.3420 | |
| KFX | Assembly, Thigh/Knee/Shank/Ankle/Foot, External | 第 2 类 | 21 CFR 890.3500 | 4 |
| KGH | Unit, Wrist, External Limb Component, Powered | 第 1 类 | 21 CFR 890.3420 | |
| KHX | Platform, Force-Measuring | 第 1 类 | 21 CFR 890.1575 | 15 |
| KHY | Cane, Safety Walk | 第 1 类 | 21 CFR 890.3075 | |
| KIC | Cushion, Flotation | 第 1 类 | 21 CFR 890.3175 | 29 |
| KID | Restraint, Wheelchair, Non-Protective | 第 1 类 | 21 CFR 890.3910 | 7 |
| KNL | Board, Scooter, Prone | 第 1 类 | 21 CFR 890.5370 | 5 |
| KNM | Device, Pressure Applying | 第 1 类 | 21 CFR 890.5765 | 2 |
| KNN | Components, Wheelchair | 第 1 类 | 21 CFR 890.3920 | 64 |
| KNO | Accessories, Wheelchair | 第 1 类 | 21 CFR 890.3910 | 35 |
| KNP | Orthosis, Corrective Shoe | 第 1 类 | 21 CFR 890.3475 | 7 |
| KTB | Device, Iontophoresis, Specific Uses | 第 2 类 | 21 CFR 890.5525 | 16 |
| KTC | Bath, Sitz, Nonpowered | 第 1 类 | 21 CFR 890.5125 | 7 |
| KTD | Orthosis, Abdominal | 第 1 类 | 21 CFR 890.3490 | 3 |
| KZM | Device, Muscle Monitoring | 第 2 类 | 21 CFR 890.1375 | 19 |
| LBE | Stroller, Adaptive | 第 1 类 | 21 CFR 890.3850 | 8 |
| LBG | Device, Fluidized Therapy, Dry Heat | 第 2 类 | 21 CFR 890.5500 | 1 |
| LFF | Unit, Activation, Breath Control | 第 1 类 | 21 CFR 890.3920 | 1 |
| LHC | Warmer, Irrigation Solution | 第 1 类 | 21 CFR 890.5950 | 24 |
| LQX | Device, Finger-Sucking | 第 1 类 | 21 CFR 890.3475 | 2 |
| LSB | Unit, Fluidotherapy | 第 2 类 | 21 CFR 890.5100 | 4 |
| LXF | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep He | 第 3 类 | 21 CFR 890.5300 | |
| LXJ | Interactive Rehabilitation Exercise Devices | 第 2 类 | 21 CFR 890.5360 | 27 |
| LYG | Massager, Therapeutic, Manual | 第 1 类 | 21 CFR 890.5660 | 13 |
| LYH | Arthrometer | 第 1 类 | 21 CFR 890.1615 | 5 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | 第 1 类 | 21 CFR 890.3475 | 2 |
| MOC | Cushion, Flotation, Therapeutic | 第 2 类 | 21 CFR 890.5170 | 2 |
| MPO | Infant Heel Warmer (Chemical Heat Pack) | 第 1 类 | 21 CFR 890.5710 | 11 |
| MRI | Orthosis, Truncal/Orthosis, Limb | 第 1 类 | 21 CFR 890.3490 | 2 |
| MWZ | Expander, Breast, External | 第 1 类 | 21 CFR 890.5660 | 1 |
| NDA | Helmet, Cranial, For Protective Use | 第 1 类 | 21 CFR 890.3025 | |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 第 2 类 | 21 CFR 890.5850 | 163 |
| NHF | Monitor, Orthotic/Prosthetic | 第 1 类 | 21 CFR 890.3025 | |
| NHH | Device, Discharge, Electrostatic (For Pain Relief) | 第 2 类 | 21 CFR 890.5500 | 2 |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effe | 第 2 类 | 21 CFR 890.5500 | 54 |
| NJB | Orthosis, Truncal, For Dysmenorrhea | 第 1 类 | 21 CFR 890.3490 | 1 |
| NUW | Stimulator, Muscle, Powered, Dental | 第 2 类 | 21 CFR 890.5850 | 9 |
| NXB | Dispenser, Solid Medication | 第 1 类 | 21 CFR 890.5050 | 3 |
| NXE | Walker, Mechanical, Poly Vinyl Chloride (Pvc) | 第 1 类 | 21 CFR 890.3825 | 1 |
| NXQ | Reminder, Medication | 第 1 类 | 21 CFR 890.5050 | 2 |
| NYY | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation | 第 2 类 | 21 CFR 890.5850 | |
| NYZ | Stimulator, Muscle, Powered, With Limited Output, For Muscle Condition | 第 2 类 | 21 CFR 890.5850 | |
| NZY | Light, Lymphedema Reduction, Low Energy | 第 2 类 | 21 CFR 890.5500 | 1 |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | 第 1 类 | 21 CFR 890.5050 | |
| OAL | Exercise Equipment, Powered, Emg-Triggered | 第 2 类 | 21 CFR 890.1375 | 1 |
| OAP | Laser, Comb, Hair | 第 2 类 | 21 CFR 890.5500 | 112 |
| OHI | Orthosis, Foot Drop | 第 1 类 | 21 CFR 890.3475 | 1 |
| OIZ | Foot Examination Tool For Inflammatory Changes | 第 1 类 | 21 CFR 890.5050 | 2 |
| OJL | Insulin Vial Protector/Holder | 第 1 类 | 21 CFR 890.5050 | |
| OMW | Adhesive Backed Thermal Skin Patches | 第 1 类 | 21 CFR 890.5710 | |
| OSD | Massager, Therapeutic, To Internally Massage Trigger Points In The Pel | 第 2 类 | 21 CFR 890.5670 | 2 |
| OTX | Foot Wrap For Treating Restless Leg Syndrome Symptoms | 第 1 类 | 21 CFR 890.5760 | 1 |
| OVP | Vibratory Counter-Stimulation | 第 2 类 | 21 CFR 882.5895 | 1 |