K201982 is an FDA 510(k) clearance for the Air compression therapy system FO-3001. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Foshan Hongfeng Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on March 25, 2021, 251 days after receiving the submission on July 17, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K201982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 251 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 |