IMPALA

Wheelchair, Mechanical

PIN DOT PRODUCTS, INC.

The following data is part of a premarket notification filed by Pin Dot Products, Inc. with the FDA for Impala.

Pre-market Notification Details

• Device ID: K913512
• 510k Number: K913512
• Device Name: IMPALA
• Classification: Wheelchair, Mechanical
• Applicant: PIN DOT PRODUCTS, INC. 6001 GROSS POINT RD. Niles, IL 60648 -4027
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-08-07
• Decision Date: 1991-08-29