FLEXMATE

Stimulator, Nerve, Transcutaneous, For Pain Relief

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Flexmate.

Pre-market Notification Details

• Device ID: K934619
• 510k Number: K934619
• Device Name: FLEXMATE
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112
• Contact: Kirby J Kuhlemeier
• Correspondent: Kirby J Kuhlemeier; MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-27
• Decision Date: 1994-02-23