COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1

Stimulator, Nerve, Transcutaneous, For Pain Relief

BIOMEDICAL LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Combination Powered Electrical Muscle Stimulator And Interferential Stimulator, Model Bmls04-1.

Pre-market Notification Details

• Device ID: K041388
• 510k Number: K041388
• Device Name: COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY P.O. BOX 1360 Vista, CA 92085 -1360
• Contact: Gary Bussett
• Correspondent: Gary Bussett; BIOMEDICAL LIFE SYSTEMS, INC. 2448 CADES WAY P.O. BOX 1360 Vista, CA 92085 -1360
• Product Code: GZJ
• Subsequent Product Code: IPF
• Subsequent Product Code: LIH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-25
• Decision Date: 2004-11-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857771003231	K041388	000