ViMove2
by Dorsavi Ltd
510(k) K163150
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163150 | Date14 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K163150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IKN
- FDA applicant
- Dorsavi, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
ViMove2 is an electromyograph, diagnostic device used in physical medicine. It is a wearable sensor technology system that includes motion sensors and a software interface for assessment and monitoring.
The device is supplied as a system for clinical or outdoor use, supporting patient assessment, coaching, and out-of-clinic monitoring. It is authorized under FDA 510(k) clearance (K163150) and is classified as a Class II medical device.
Devices cleared under K163150
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Professional Suite 0000PS100 | PS100 / 0000PS100 | B7580000PS100 | — | On the market |
| ViMove+ 000VMPLU0 | VMPLU / 000VMPLU0 | B758000VMPLU0 | — | On the market |
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