Product code IPF
- Device name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5850
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 |
| K230167 | BACK 4 | Swims America Corp | 2023-09-14 |
| K232334 | DEKA SIMON | El.En S.P.A. | 2023-09-01 |
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | 2023-01-17 |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | 2022-10-21 |
| K221958 | Flex-MI | Emsi, Inc. | 2022-10-21 |
| K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022-10-14 |
| K213197 | MyOnyx System | Thought Technology , Ltd. | 2022-06-17 |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022-05-12 |
| K220327 | geko W-3 | Firstkind Limited | 2022-03-04 |
| K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | 2022-02-25 |
| K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021-12-14 |
| K212762 | geko W-2 | Firstkind Limited | 2021-11-29 |
| K192746 | MyoWorx TM20 | Myoworx, Inc. | 2021-10-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03770018808086 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808093 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808109 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808116 | actiTENS | SUBLIMED | 2026-05-27 |
| 03770018808253 | actiTENS Mini | SUBLIMED | 2026-05-27 |
| 03770018808260 | actiTENS Mini | SUBLIMED | 2026-05-27 |
| 07898966442698 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2026-04-22 |
| 07898966442551 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2026-04-22 |
| 08032625824480 | GLOBUS | DOMINO SRL | 2026-02-23 |
| 08032625822875 | GLOBUS | DOMINO SRL | 2024-11-20 |
| 08032625822868 | GLOBUS | DOMINO SRL | 2024-11-20 |
| 08032625822882 | GLOBUS | DOMINO SRL | 2024-11-20 |
| 08032625828037 | GLOBUS | DOMINO SRL | 2024-10-17 |
| 08032625829799 | GLOBUS | DOMINO SRL | 2024-10-17 |
| 08032625829805 | GLOBUS | DOMINO SRL | 2024-10-17 |
| 08032625822851 | GLOBUS | DOMINO SRL | 2024-10-17 |
| 08032625829812 | GLOBUS | DOMINO SRL | 2024-10-17 |
| 08032625825265 | GLOBUS | DOMINO SRL | 2024-09-04 |
| 08032625828020 | GLOBUS | DOMINO SRL | 2024-09-04 |
| 08032625822837 | GLOBUS | DOMINO SRL | 2024-09-04 |
| 08032625822844 | GLOBUS | DOMINO SRL | 2024-09-04 |
| 08592566001055 | DuoMAG NL | DEYMED Diagnostic s.r.o. | 2021-06-29 |
| 00815290017719 | Therapist’s Choice® TENS 7500 | CLINICAL HEALTH SERVICES, INC. | 2021-02-10 |
| 08057017760535 | DEKA PHYSIQ | EL.EN. SPA | 2020-12-11 |
| 07898961579115 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579108 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579054 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579047 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579016 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-03-17 |
| FA216218 | Xcite | RESTORATIVE THERAPIES, INC. | 2016-12-21 |