IPF — Stimulator, Muscle, Powered Class II
FDA Device Classification
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 |
|---|
| 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 |
| K232334 | el.en | DEKA SIMON | September 1, 2023 |
| K213655 | hilltek | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | January 17, 2023 |
| K222201 | medlander medical technology | Biological Feedback and Stimulation System | October 21, 2022 |