The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens,model Systems Plus/a.
| Device ID | K905569 |
| 510k Number | K905569 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 1285 STONE DR. #103 P.O. BOX 128 San Marcos, CA 92069 |
| Contact | Richard Saxon |
| Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. 1285 STONE DR. #103 P.O. BOX 128 San Marcos, CA 92069 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-06-27 |