The following data is part of a premarket notification filed by Woodside Biomedical, Inc. with the FDA for Reliefband Nst Device Models Wb-2,wb-6,wb-r.
Device ID | K983907 |
510k Number | K983907 |
Device Name: | RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | WOODSIDE BIOMEDICAL, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
Contact | Carol L Patterson |
Correspondent | Carol L 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 | 1998-11-03 |
Decision Date | 1999-12-09 |