GLOBALCARE MICRO 11 AND MICROCARE (TENS)

Stimulator, Nerve, Transcutaneous, For Pain Relief

GLOBALCARE INTL., INC.

The following data is part of a premarket notification filed by Globalcare Intl., Inc. with the FDA for Globalcare Micro 11 And Microcare (tens).

Pre-market Notification Details

• Device ID: K903394
• 510k Number: K903394
• Device Name: GLOBALCARE MICRO 11 AND MICROCARE (TENS)
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: GLOBALCARE INTL., INC. 220 LINDEN ST. Holyoke, MA 01040
• Contact: John Dunn
• Correspondent: John Dunn; GLOBALCARE INTL., INC. 220 LINDEN ST. Holyoke, MA 01040
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-27
• Decision Date: 1991-05-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06975869140041	K903394	000