ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9

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 Electro-nerve Stimulator Tens, Model Bmls02-9.

Pre-market Notification Details

• Device ID: K022841
• 510k Number: K022841
• Device Name: ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360
• Contact: Richard Saxon
• Correspondent: Richard Saxon; BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-08-27
• Decision Date: 2002-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00749756795692	K022841	000
00749756777452	K022841	000
00749756774413	K022841	000
00749756774406	K022841	000
00749756748704	K022841	000
00749756748698	K022841	000
00749756748681	K022841	000
00749756939348	K022841	000
00857771003071	K022841	000