CADDY

Wheelchair, Powered

AFIKIM ELECTRIC VEHICLES

The following data is part of a premarket notification filed by Afikim Electric Vehicles with the FDA for Caddy.

Pre-market Notification Details

• Device ID: K041186
• 510k Number: K041186
• Device Name: CADDY
• Classification: Wheelchair, Powered
• Applicant: AFIKIM ELECTRIC VEHICLES Kibbutz Afikim, IL 15148
• Contact: Avner Fishbein
• Correspondent: Avner Fishbein; AFIKIM ELECTRIC VEHICLES Kibbutz Afikim, IL 15148
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-05-06
• Decision Date: 2004-09-09