MODEL 9000 PEDIATRIC WHEELCHAIR

Wheelchair, Mechanical

INVACARE CORP.

The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model 9000 Pediatric Wheelchair.

Pre-market Notification Details

• Device ID: K002170
• 510k Number: K002170
• Device Name: MODEL 9000 PEDIATRIC WHEELCHAIR
• Classification: Wheelchair, Mechanical
• Applicant: INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125
• Contact: Edward A Kroll
• Correspondent: Edward A Kroll; INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 -2125
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-19
• Decision Date: 2000-08-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841447102793	K002170	000