The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Interferential Stimulator Model Imf4150/a.
Device ID | K925687 |
510k Number | K925687 |
Device Name: | INTERFERENTIAL STIMULATOR MODEL IMF4150/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 | 1992-11-12 |
Decision Date | 1993-03-29 |