K251622 is an FDA 510(k) clearance for the Hand Massager (SM004D). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 28, 2026, 245 days after receiving the submission on May 28, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K251622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2025 |
| Decision Date | January 28, 2026 |
| Days to Decision | 245 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 |