K201645 is an FDA 510(k) clearance for the Massage Compression Boots. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Jkh USA, LLC (Walnut, US). The FDA issued a Cleared decision on September 15, 2020, 90 days after receiving the submission on June 17, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K201645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2020 |
| Decision Date | September 15, 2020 |
| Days to Decision | 90 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 |