The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens Model C & B11, B11c.
| Device ID | K871126 |
| 510k Number | K871126 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 39636 Los Angeles, CA 90039 |
| Contact | Richard G Saxon |
| Correspondent | Richard G Saxon BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 39636 Los Angeles, CA 90039 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-20 |
| Decision Date | 1987-06-02 |