K200351 is an FDA 510(k) clearance for the PlasmaFlight. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on August 5, 2020, 175 days after receiving the submission on February 12, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K200351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2020 |
| Decision Date | August 05, 2020 |
| Days to Decision | 175 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 |