JOW
- Product code
- JOW
- Device name
- Sleeve, Limb, Compressible
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5800
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 352
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253555 | 2026-07-31 | Tactile Medical | Flexitouch® Plus Advanced Pneumatic Compression Syst | |
| K253386 | 2026-06-25 | Vistar Medical Supplies Co., Ltd. | DVT Garment | |
| K250242 | 2026-04-24 | Guangzhou Longest Medical Technology C | Compression Therapy Device (LGT-2202DVT) | |
| K254267 | 2026-02-24 | Mego Afek , Ltd. | NanoPress 760A-BT (760A-BT) | — |
| K250974 | 2025-12-12 | Bio Compression Systems, Inc. | Bio Arterial Deluxe (IC-BAP-DX) | |
| K250190 | 2025-12-08 | Shenzhen Comen Medical Instruments Co. | Sequential Compression System (SCD600) | |
| K251466 | 2025-10-28 | Wellell, Inc. | VenAir, Sequential Compression System (9P-089000); V | |
| K251446 | 2025-09-17 | Manamed, LLC | PlasmaFlow X Compression Sleeve Device (XPF0001) | — |
| K251086 | 2025-08-18 | Biotab, LLC | PnueAira (PNCU-01) | |
| K250817 | 2025-08-08 | Vive Health, LLC | Coretech Compression System (Coretech RHB3003) | |
| K241096 | 2025-01-15 | Suzhou Minhua Medical Apparatus Suppli | Venera 608 Deep Vein Thrombosis (DVT) Prevention Sys | |
| K240499 | 2024-10-11 | Airos Medical, Inc. | ARTAIRA Arterial Compression Device (AACD01) | |
| K241746 | 2024-10-04 | United Medical Resources, LLC | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED RE | — |
| K232640 | 2024-06-25 | Thermabright | Venowave VW5 | FDA |
| K240125 | 2024-06-21 | Zenith Technical Innovations | Therm-X (Home); Therm-X (AT) | |
| K234155 | 2024-06-21 | Tactile Medical | Nimbl (model PD08-N1) | FDA |
| K232270 | 2024-03-06 | Koge Micro Tech Co., Ltd. | DVT Motion Pneumatic Compression Device | |
| K240011 | 2024-02-23 | Jkh Health Co., Ltd. | Lymphedema Compression | |
| K223228 | 2024-01-04 | Koya Medical, Inc. | Dayspring | |
| K232300 | 2023-12-22 | Elastimed , Ltd. | ElastiMed SACS | FDA |
| K231801 | 2023-12-14 | Medhealth Medical Limited | MedHealth DVT compression Devices MHH900S/MHH900E | FDA |
Official FDA classification page: JOW
Classification and pathway per current FDA publications. Data from openFDA (CC0).