TENSTAR

Stimulator, Nerve, Transcutaneous, For Pain Relief

HEALTHCHECK CORP.

The following data is part of a premarket notification filed by Healthcheck Corp. with the FDA for Tenstar.

Pre-market Notification Details

• Device ID: K874818
• 510k Number: K874818
• Device Name: TENSTAR
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410
• Contact: Balzer, Jr.
• Correspondent: Balzer, Jr.; HEALTHCHECK CORP. 150 SANDBANK RD. Cheshire, CT 06410
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-11-24
• Decision Date: 1988-09-28