The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens Model Biomed 2000/a.
| Device ID | K905570 |
| 510k Number | K905570 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A |
| Classification | Stimulator, Nerve, Transcutaneous, For 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-12 |
| Decision Date | 1991-06-04 |