K211823 is an FDA 510(k) clearance for the Bonine Acupressure Bands. This device is classified as a Device, Acupressure.
Submitted by Wellspring Pharmaceutical Corporation (Sarasota, US). The FDA issued a Cleared decision on September 1, 2021, 79 days after receiving the submission on June 14, 2021.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K211823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2021 |
| Decision Date | September 01, 2021 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVV - Device, Acupressure |
| Device Class | - |