FDA product code IPF: Stimulator, Muscle, Powered
IPF is the FDA product code for stimulator, muscle, powered. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel. FDA has cleared 548 510(k) submissions under IPF, 29 in the last five years, from 311 different applicants. The average 510(k) review took 157 days (median 108); 224 days on average over the last three years. FDA has posted 7 recalls for IPF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Muscle, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5850 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IPF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 100 |
| 2018 | 5 | 95 |
| 2019 | 4 | 171 |
| 2020 | 9 | 152 |
| 2021 | 15 | 175 |
| 2022 | 7 | 128 |
| 2023 | 9 | 266 |
| 2024 | 7 | 207 |
| 2025 | 3 | 264 |
| 2026 | 3 | 201 |
Compare with all 510(k) review times · Search every IPF clearance
Top IPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rich-Mar Corp. | 17 | 2003-10-22 |
| Bloomex International, Inc. | 14 | 1995-08-14 |
| Mettler Electronics Corp. | 11 | 2012-06-26 |
| Chattanooga Group, Inc. | 11 | 1998-11-06 |
| Maximum Performance Technologies, Mpts, Inc. | 11 | 1991-12-10 |
306 more applicants have IPF clearances. See the full list in Caduvo.
Most recent IPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253542 | Weero Co., Ltd. | Apollo Quattro (APQ-10M) | 2026-06-08 | 206 |
| K252816 | Mohammadali Nezakati | High Tone Power therapy (HiToP) (Model: HiToP PNP) | 2026-06-02 | 271 |
| K260142 | Motion Informatics ltd. | StimelMD (SSMD) system | 2026-05-27 | 127 |
| K251083 | Enraf-Nonius, B.V. | Compact II | 2025-09-12 | 156 |
| K241433 | Weero Co., Ltd. | EVE Synergy (EVE-20M) | 2025-06-04 | 379 |
Recalls for IPF devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-03.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code IPF?
IPF is the FDA product code for stimulator, muscle, powered. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel.
What device class is IPF?
Class II, regulation 21 CFR 890.5850. Typical premarket route: 510(k).
How long does a 510(k) take for product code IPF?
Across 548 cleared submissions the average was 157 days from receipt to decision (median 108).
Which companies have the most IPF clearances?
Rich-Mar Corp. (17); Bloomex International, Inc. (14); Mettler Electronics Corp. (11); Chattanooga Group, Inc. (11); Maximum Performance Technologies, Mpts, Inc. (11).
Have IPF devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2023-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code IPF
- Run a recall and safety report across every IPF manufacturer
- Watch product code IPF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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