K171685 is an FDA 510(k) clearance for the Med4 Elite. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Cool Systems, Inc. (Dba Game Ready) (Concord, US). The FDA issued a Cleared decision on September 29, 2017, 114 days after receiving the submission on June 7, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K171685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2017 |
| Decision Date | September 29, 2017 |
| Days to Decision | 114 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 |