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 |
|---|
| 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 |
| K221958 | Flex-MI | Emsi, Inc. | 2022-10-21 |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, 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 |
| K210002 | STELLA BIO | Egzotech Sp. Z O. O. | 2021-10-01 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 08809308380782 | Compact-II | Enraf-Nonius B.V. | 2025-09-23 |
| 18885022060015 | Quantum Mitohormesis (QMT) | QUANTUMTX PTE. LTD. | 2025-07-21 |
| 00810188050083 | L300 Go System | Bioness Medical, Inc. | 2025-07-18 |
| 00810188050120 | L300 Go System | Bioness Medical, Inc. | 2025-07-18 |
| 00810188050274 | L300 Go System | Bioness Medical, Inc. | 2025-07-18 |
| 00810188050342 | L300 Go System | Bioness Medical, Inc. | 2025-07-17 |
| 00810188050243 | L300 Go System | Bioness Medical, Inc. | 2025-07-17 |
| 00810188050137 | L300 Go System | Bioness Medical, Inc. | 2025-07-17 |
| 00810188050113 | L300 Go System | Bioness Medical, Inc. | 2025-07-17 |
| 00810188050090 | L300 Go System | Bioness Medical, Inc. | 2025-07-17 |
| 00810188050069 | L360 Thigh System | Bioness Medical, Inc. | 2025-07-17 |
| 08809851470091 | EVE Synergy; EVE Titan | WEERO Co., Ltd. | 2025-06-24 |
| 03830054238138 | QuantumStar, StarFormer | FOTONA d.o.o. | 2025-06-12 |
| 00860009465626 | STIMEL-03 Stimulating Electrodes | MOTION INFORMATICS LTD | 2024-11-26 |
| 00860009465602 | STIMEL-03 | MOTION INFORMATICS LTD | 2024-11-17 |
| 17540176050091 | Prelivia | Rehabtronics Inc | 2024-11-12 |
| 17540176050107 | Prelivia Electrode | Rehabtronics Inc | 2024-11-12 |
| 17540176050114 | Prelivia Electrode | Rehabtronics Inc | 2024-11-12 |
| 10810113577194 | Vive | VIVE HEALTH LLC | 2024-08-20 |
| 00850022650468 | Motive Knee System | Motive Health, Inc. | 2024-08-12 |
| 00850022650451 | Motive Knee System | Motive Health, Inc. | 2024-08-12 |
| 00850022650444 | Motive Knee System | Motive Health, Inc. | 2024-08-12 |
| 16971763600190 | ROOVJOY | Shenzhen roundwhale technology co. LTD. | 2024-07-31 |
| 03830054237728 | StarFormer | FOTONA d.o.o. | 2024-07-30 |
| 00092237626047 | Richmar EMG Pro | COMPASS HEALTH BRANDS CORP. | 2024-06-28 |
| 00092237626054 | Richmar EMG Pro | COMPASS HEALTH BRANDS CORP. | 2024-06-28 |
| 00850022650291 | Motive Knee System | Motive Health, Inc. | 2024-04-11 |
| 00092237616642 | Richmar | COMPASS HEALTH BRANDS CORP. | 2016-10-12 |
| 08908008085192 | Mettler Electronics Corp. | SYRMA JOHARI MEDTECH LIMITED | 2016-09-19 |
| 08908008085130 | Johari Digital Healthcare Limited | SYRMA JOHARI MEDTECH LIMITED | 2016-09-19 |