The following data is part of a premarket notification filed by Woodside Biomedical, Inc. with the FDA for Reliefband Mst Device, Models Rb-2, Rb-6, Rb-r.
| Device ID | K982967 |
| 510k Number | K982967 |
| Device Name: | RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WOODSIDE BIOMEDICAL, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson WOODSIDE BIOMEDICAL, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-25 |
| Decision Date | 1999-02-23 |