The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Interferential Stimulator, Model Bmls03-6.
| Device ID | K040824 |
| 510k Number | K040824 |
| Device Name: | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 |
| Classification | Interferential Current Therapy |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Contact | Gary Bussett |
| Correspondent | Gary Bussett BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-30 |
| Decision Date | 2004-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003217 | K040824 | 000 |