The following data is part of a premarket notification filed by Wellspring Pharmaceutical Corporation with the FDA for Bonine Acupressure Bands.
| Device ID | K211823 |
| 510k Number | K211823 |
| Device Name: | Bonine Acupressure Bands |
| Classification | Device, Acupressure |
| Applicant | WellSpring Pharmaceutical Corporation 5911 North Honore Avenue, Suite 211 Sarasota, FL 34243 |
| Contact | Renee Davis Grandchamp |
| Correspondent | Mikel Alberdi Drug Device Consulting 13014 N. Dale Mabry Hwy., #326 Tampa, FL 33618 |
| Product Code | MVV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-14 |
| Decision Date | 2021-09-01 |