ALEXIS

Wheelchair, Powered

INTEX RESEARCH & DEVELOPMENT CENTER

The following data is part of a premarket notification filed by Intex Research & Development Center with the FDA for Alexis.

Pre-market Notification Details

• Device ID: K851261
• 510k Number: K851261
• Device Name: ALEXIS
• Classification: Wheelchair, Powered
• Applicant: INTEX RESEARCH & DEVELOPMENT CENTER 921 ALMA ST. Palo Alto, CA 94301
• Contact: Peter Axelson
• Correspondent: Peter Axelson; INTEX RESEARCH & DEVELOPMENT CENTER 921 ALMA ST. Palo Alto, CA 94301
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-03-28
• Decision Date: 1985-07-01