The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens Model Micro Plus-a.
| Device ID | K915210 |
| 510k Number | K915210 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 1120 SYCAMORE AVE., STE F P.O. BOX 1360 Vista, CA 92083 |
| Contact | Richard Saxon |
| Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. 1120 SYCAMORE AVE., STE F P.O. BOX 1360 Vista, CA 92083 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-18 |
| Decision Date | 1992-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003163 | K915210 | 000 |