K192607 is an FDA 510(k) clearance for the LiteWalk. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on December 19, 2019, 90 days after receiving the submission on September 20, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K192607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | December 19, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |