The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens, Model Bmls06-1.
| Device ID | K061476 |
| 510k Number | K061476 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Contact | Gary Bussett |
| Correspondent | Gary Bussett BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-30 |
| Decision Date | 2006-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003156 | K061476 | 000 |
| 00857771003149 | K061476 | 000 |
| 00857771003095 | K061476 | 000 |