HELPING HAND

Wheelchair, Powered

KINETIC REHABILITATION INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Kinetic Rehabilitation Instruments, Inc. with the FDA for Helping Hand.

Pre-market Notification Details

• Device ID: K954427
• 510k Number: K954427
• Device Name: HELPING HAND
• Classification: Wheelchair, Powered
• Applicant: KINETIC REHABILITATION INSTRUMENTS, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Contact: Terry G Mahn
• Correspondent: Terry G Mahn; KINETIC REHABILITATION INSTRUMENTS, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-22
• Decision Date: 1996-09-16