K232965 is an FDA 510(k) clearance for the Leg Massager (Models:RP-ALM070H, RP-ALM071H). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Shenzhen Ruiyi Business Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 20, 2024, 426 days after receiving the submission on September 21, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K232965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2023 |
| Decision Date | November 20, 2024 |
| Days to Decision | 426 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 |