LiteWalk
by Viasonix Ltd
LiteWalk, a sequential venous compression system (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Viasonix Ltd, was cleared under FDA 510(k) K192607 on 19 Dec 2019 and listed in FDA GUDID on 19 Jun 2020 (UDI-DI 07290016880250); the registry lists it as not in commercial distribution (GUDID) as of 31 May 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016880250 | Date19 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192607 | Date19 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 07290016880250
- FDA 510(k) database K192607
Across registries
- FDA 510(k) K192607 decided 19 Dec 2019 Active
- FDA GUDID UDI-DI 07290016880250 listed 19 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K192607
- Listed FDA GUDID 07290016880250
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Sequential venous compression system
- Model / reference
- LiteWalk
- Primary DI / UDI-DI
- 07290016880250
- 510(k) Number
- FDA product code
- IRP
- GMDN term
- Sequential venous compression system
- Device class
- Class II
- Regulation number
- 890.5650
- GUDID distribution status
- Not in Commercial Distribution
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