K193383 is an FDA 510(k) clearance for the SnugKap. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Headstart, Ltd. (Elk Grove Village, US). The FDA issued a Cleared decision on June 7, 2021, 550 days after receiving the submission on December 5, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | K193383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2019 |
| Decision Date | June 07, 2021 |
| Days to Decision | 550 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVA - Orthosis, Cranial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |