LiteWalk
by Viasonix Ltd
510(k) K192607
LiteWalk is a medical device (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Viasonix Ltd, cleared under FDA 510(k) K192607 on 19 Dec 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192607 | Date19 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K192607
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IRP
- FDA applicant
- Viasonix , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192607
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 | |||
|---|---|---|---|---|
| LiteWalk | LiteWalk | 07290016880250 | — | No longer on the market |
| LiteWalk Sandals Large | PVC0268-L / Large | 07290016880267 | — | No longer on the market |
| LiteWalk Sandals Medium | PVC0268-M / Medium | 07290016880274 | — | No longer on the market |
| LiteWalk Sandals Small | PVC0268-S / Small | 07290016880281 | — | No longer on the market |
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