The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Interferential Stimulator Model Inf 4150/a.
| Device ID | K921441 |
| 510k Number | K921441 |
| Device Name: | INTERFERENTIAL STIMULATOR MODEL INF 4150/A |
| Classification | Interferential Current Therapy |
| 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 | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-25 |
| Decision Date | 1992-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003132 | K921441 | 000 |