K160608 is an FDA 510(k) clearance for the NormaTec Pulse and NormaTec Pulse Pro. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by NormaTec Industries, LP (Newton, US). The FDA issued a Cleared decision on April 13, 2016, 41 days after receiving the submission on March 3, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K160608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2016 |
| Decision Date | April 13, 2016 |
| Days to Decision | 41 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 |