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 |