The following data is part of a premarket notification filed by Woodside Biomedical, Inc. with the FDA for Reliefband Nst Device, Model Wb-2l, Wb-6l, Wb-rl.
Device ID | K994387 |
510k Number | K994387 |
Device Name: | RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-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 | 1999-12-28 |
Decision Date | 2000-03-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20661168300018 | K994387 | 000 |