K222949 is an FDA 510(k) clearance for the Air Compression Leg Massager (Model: LY-670D). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Zhejiang Luyao Electronics Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on December 22, 2022, 86 days after receiving the submission on September 27, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K222949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2022 |
| Decision Date | December 22, 2022 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |