The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro-nerve Stimulator Tens, Model Lx.
| Device ID | K990230 |
| 510k Number | K990230 |
| Device Name: | ELECTRO-NERVE STIMULATOR TENS, MODEL LX |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY Vista, CA 92083 |
| Contact | Richard Saxon |
| Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY Vista, CA 92083 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-08-19 |