The following data is part of a premarket notification filed by Acuband Inc. with the FDA for Acuband Acupressure Wrist Band Device.
| Device ID | K053509 |
| 510k Number | K053509 |
| Device Name: | ACUBAND ACUPRESSURE WRIST BAND DEVICE |
| Classification | Device, Acupressure |
| Applicant | ACUBAND INC. 101 LITTLE SILVER POINT ROAD Little Silver, NJ 07739 |
| Contact | Richard Griffith |
| Correspondent | Richard Griffith ACUBAND INC. 101 LITTLE SILVER POINT ROAD Little Silver, NJ 07739 |
| 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 | 2005-12-16 |
| Decision Date | 2006-08-16 |
| Summary: | summary |