K183169 is an FDA 510(k) clearance for the Pulse 2.0, Pulse Pro 2.0. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by NormaTec Industries, LP (Watertown, US). The FDA issued a Cleared decision on December 27, 2018, 41 days after receiving the submission on November 16, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K183169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2018 |
| Decision Date | December 27, 2018 |
| 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 |