DOMINATOR

Wheelchair, Mechanical

IMPACT WHEELCHAIR MANUFACTURE, INC.

The following data is part of a premarket notification filed by Impact Wheelchair Manufacture, Inc. with the FDA for Dominator.

Pre-market Notification Details

• Device ID: K983681
• 510k Number: K983681
• Device Name: DOMINATOR
• Classification: Wheelchair, Mechanical
• Applicant: IMPACT WHEELCHAIR MANUFACTURE, INC. 1255 UNIVERSITY ROOM 1604 Montreal, CA H3b-3x3
• Contact: Zave Aberman
• Correspondent: Zave Aberman; IMPACT WHEELCHAIR MANUFACTURE, INC. 1255 UNIVERSITY ROOM 1604 Montreal, CA H3b-3x3
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-20
• Decision Date: 1998-11-27