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 |