BESMED VARIOUS MODELS OF TENS, BE-550/BE-660

Stimulator, Nerve, Transcutaneous, For Pain Relief

BESMED HEALTH BUSINESS CORP.

The following data is part of a premarket notification filed by Besmed Health Business Corp. with the FDA for Besmed Various Models Of Tens, Be-550/be-660.

Pre-market Notification Details

• Device ID: K031374
• 510k Number: K031374
• Device Name: BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300
• Contact: Dr. Jen Ke Min
• Correspondent: Dr. Jen Ke Min; BESMED HEALTH BUSINESS CORP. 58 FU-CHIUN ST. Hsin Chu City, TW 300
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-30
• Decision Date: 2003-11-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04716770926605	K031374	000
04716770925509	K031374	000