JAZZY

Wheelchair, Powered

PRIDE HEALTH CARE, INC.

The following data is part of a premarket notification filed by Pride Health Care, Inc. with the FDA for Jazzy.

Pre-market Notification Details

• Device ID: K945936
• 510k Number: K945936
• Device Name: JAZZY
• Classification: Wheelchair, Powered
• Applicant: PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644
• Contact: George Amadei
• Correspondent: George Amadei; PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-05
• Decision Date: 1996-05-28