K241446 is an FDA 510(k) clearance for the Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Sichuan Qianii-Beoka Medical Technoiogy Lnc. (Chengdu, CN). The FDA issued a Cleared decision on October 8, 2024, 139 days after receiving the submission on May 22, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K241446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2024 |
| Decision Date | October 08, 2024 |
| Days to Decision | 139 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 |