STARTRAC

Treadmill, Powered

UNISEN, INC.

The following data is part of a premarket notification filed by Unisen, Inc. with the FDA for Startrac.

Pre-market Notification Details

• Device ID: K890793
• 510k Number: K890793
• Device Name: STARTRAC
• Classification: Treadmill, Powered
• Applicant: UNISEN, INC. 14352 CHAMBERS RD. Tustin, CA 92680
• Contact: Jim Pittaway
• Correspondent: Jim Pittaway; UNISEN, INC. 14352 CHAMBERS RD. Tustin, CA 92680
• Product Code: IOL
• CFR Regulation Number: 890.5380 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-02-17
• Decision Date: 1989-03-16