DYNAMO

Vehicle, Motorized 3-wheeled

PRIDE HEALTH CARE, INC.

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

Pre-market Notification Details

• Device ID: K944277
• 510k Number: K944277
• Device Name: DYNAMO
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644
• Contact: Thomas E Kretchik
• Correspondent: Thomas E Kretchik; PRIDE HEALTH CARE, INC. 259 WEST 6TH ST. West Wyoming, PA 18644
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-08-30
• Decision Date: 1994-12-28