The following data is part of a premarket notification filed by Biomedical Life Systems with the FDA for Electro-nerve Stimulator Tens Model Bmls02-3.
| Device ID | K021271 |
| 510k Number | K021271 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS P.O. BOX 1360 Vista, CA 92085 |
| Contact | Hans Reiss |
| Correspondent | Hans Reiss BIOMEDICAL LIFE SYSTEMS P.O. BOX 1360 Vista, CA 92085 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2003-02-06 |