The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Interferential Stimulator, Model Bmls02-6.
Device ID | K040007 |
510k Number | K040007 |
Device Name: | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 |
Classification | Interferential Current Therapy |
Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY P.O. BOX 1360 Vista, CA 92085 -1360 |
Contact | Richard Saxon |
Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY 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 | 2004-01-02 |
Decision Date | 2004-07-07 |