The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Litewalk.
| Device ID | K192607 |
| 510k Number | K192607 |
| Device Name: | LiteWalk |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Viasonix Ltd. 10 Hamelacha Street Raananna, IL 4366105 |
| Contact | Shlomi Deler |
| Correspondent | Shlomi Deler Viasonix Ltd. 10 Hamelacha Street Raananna, IL 4366105 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016880281 | K192607 | 000 |
| 07290016880274 | K192607 | 000 |
| 07290016880267 | K192607 | 000 |
| 07290016880250 | K192607 | 000 |