Motive™ Muscle Stimulator for Lower Back (OT01-1003)
FDA 510(k) clearance K253478 · decided 2025-11-06
Clearance details
- K-number
- K253478
- Device name
- Motive™ Muscle Stimulator for Lower Back (OT01-1003)
- Applicant
- Motive Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-10-14
- Decision date
- 2025-11-06
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- NGX
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Tempe, AZ, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Diacore (K253926) | ShenB Co., Ltd. | 2026-04-10 |
| Zionic Pro Max (EMS) (K253636) | Termosalud S.L. | 2026-03-12 |
| CoolTone (K253408) | Zimmer Medizinsysteme GmbH | 2026-01-16 |
| Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) (K252154) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| truFlex (K251594) | Syrma Johari Medtech Limited | 2025-08-28 |
| TENS and EMS Unit (K251706) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| CoolTone (K251378) | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| Pure Impact (K251746) | Sofwave Medical, Ltd. | 2025-07-02 |
| 3 in 1 TENS UNIT (K250759) | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| XBody Go USA, XBody Pro USA (K242926) | Xbody Hungary Kft. | 2025-05-30 |
| Muscle Stimulator Device (PZ-100) (K250038) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| Limfa Therapy System (Limfa Therapy) (K243165) | Eywa Srl | 2025-05-15 |
Recalls involving this device
No recalls on record reference this clearance.