The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens, Model Bmls03-5.
| Device ID | K033455 |
| 510k Number | K033455 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Contact | Donna Heraty |
| Correspondent | Donna Heraty 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 | 2003-10-30 |
| Decision Date | 2004-01-15 |