K201730 is an FDA 510(k) clearance for the Powered Inflatable Tube Massager - SLIM UP DRAIN. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Foggiare Technologies, LLC (Largo, US). The FDA issued a Cleared decision on August 22, 2022, 789 days after receiving the submission on June 24, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K201730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2020 |
| Decision Date | August 22, 2022 |
| Days to Decision | 789 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 |