K161346 is an FDA 510(k) clearance for the NormaTec PCD-T and PCD-B. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by NormaTec Industries, LP (Newton, US). The FDA issued a Cleared decision on June 15, 2016, 30 days after receiving the submission on May 16, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K161346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2016 |
| Decision Date | June 15, 2016 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |