IPF
- Product code
- IPF
- Device name
- Stimulator, Muscle, Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 548
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253542 | 2026-06-08 | Weero Co., Ltd. | Apollo Quattro (APQ-10M) | |
| K252816 | 2026-06-02 | Mohammadali Nezakati | High Tone Power therapy (HiToP) (Model: HiToP PNP) | |
| K260142 | 2026-05-27 | Motion Informatics ltd. | StimelMD (SSMD) system | |
| K251083 | 2025-09-12 | Enraf-Nonius, B.V. | Compact II | |
| K241433 | 2025-06-04 | Weero Co., Ltd. | EVE Synergy (EVE-20M) | |
| K241488 | 2025-02-05 | Trainfes | TrainFES Advance | |
| K240348 | 2024-12-19 | Quantumtx Pte. , Ltd. | Quantum Mitohormesis (QMT) (M2101) | |
| K240992 | 2024-10-10 | Weero Co., Ltd. | eMVFit (MVF-10M) | FDA |
| K240234 | 2024-08-17 | BTL Industries, Inc. | BTL-899MS | |
| K233098 | 2024-08-02 | Sunmed, LLC | MYOTouch Muscle Stimulator | FDA |
| K232786 | 2024-05-16 | Edan Instruments, Inc. | Stimulation System (PA series, PR series, S series | |
| K233926 | 2024-03-21 | Mettler Electronics Corporation | accufit | |
| K233485 | 2024-01-26 | Zynex Medical, Inc. | M-Wave | — |
| K232937 | 2023-12-26 | BTL Industries, Inc. | BTL-899M | |
| K230701 | 2023-11-24 | PAJUNK GmbH Medizintechnologie | Stim2Go | |
| K231440 | 2023-11-03 | Shenzhen Roundwhale Technology Co. , L | Combo Electrotherapy Device | |
| K223027 | 2023-10-10 | Neurotrigger | NeuroTrigger Basic (NTB) | |
| K223802 | 2023-10-06 | Mettler Electronics Corporation | accufit | |
| K221274 | 2023-09-29 | Fotona D.O.O. | StarFormer, TightWave | |
| K230167 | 2023-09-14 | Swims America Corp | BACK 4 |
Official FDA classification page: IPF
Classification and pathway per current FDA publications. Data from openFDA (CC0).