IPF — Stimulator, Muscle, Powered Class II
FDA product code IPF covers "Stimulator, Muscle, Powered", a Class II medical device regulated under 21 CFR 890.5850. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IPF
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253542 | weero co | Apollo Quattro (APQ-10M) | June 8, 2026 |
| K252816 | mohammadali nezakati | High Tone Power therapy (HiToP) (Model: HiToP PNP) | June 2, 2026 |
| K260142 | motion informatics | StimelMD (SSMD) system | May 27, 2026 |
| K251083 | enraf-nonius | Compact II | September 12, 2025 |
| K241433 | weero co | EVE Synergy (EVE-20M) | June 4, 2025 |
| K241488 | trainfes | TrainFES Advance | February 5, 2025 |
| K240348 | quantumtx pte. | Quantum Mitohormesis (QMT) (M2101) | December 19, 2024 |
| K240992 | weero co | eMVFit (MVF-10M) | October 10, 2024 |
| K240234 | btl industries | BTL-899MS | August 17, 2024 |
| K233098 | sunmed | MYOTouch Muscle Stimulator | August 2, 2024 |
| K232786 | edan instruments | Stimulation System (PA series, PR series, S series and Q series) | May 16, 2024 |
| K233926 | mettler electronics corporation | accufit | March 21, 2024 |
| K233485 | zynex medical | M-Wave | January 26, 2024 |
| K232937 | btl industries | BTL-899M | December 26, 2023 |
| K230701 | pajunk gmbh medizintechnologie | Stim2Go | November 24, 2023 |
| K231440 | shenzhen roundwhale technology co. | Combo Electrotherapy Device | November 3, 2023 |
| K223027 | neurotrigger | NeuroTrigger Basic (NTB) | October 10, 2023 |
| K223802 | mettler electronics corporation | accufit | October 6, 2023 |
| K221274 | fotona | StarFormer, TightWave | September 29, 2023 |
| K230167 | swims america | BACK 4 | September 14, 2023 |