The following data is part of a premarket notification filed by Woodside Biomedical, Inc. with the FDA for Reliefband Device, Models Rb-dl, Rb-el, Rb-rl.
Device ID | K020180 |
510k Number | K020180 |
Device Name: | RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | WOODSIDE BIOMEDICAL, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson WOODSIDE BIOMEDICAL, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-18 |
Decision Date | 2002-03-21 |
Summary: | summary |