ROUGHRIDER

Wheelchair, Mechanical

WHIRLWIND WHEELCHAIR INTERNATIONAL

The following data is part of a premarket notification filed by Whirlwind Wheelchair International with the FDA for Roughrider.

Pre-market Notification Details

• Device ID: K103212
• 510k Number: K103212
• Device Name: ROUGHRIDER
• Classification: Wheelchair, Mechanical
• Applicant: WHIRLWIND WHEELCHAIR INTERNATIONAL 1600 HOLLOWAY AVENUE SCI 251 San Francisco, CA 94132
• Contact: Marc Krizack
• Correspondent: Marc Krizack; WHIRLWIND WHEELCHAIR INTERNATIONAL 1600 HOLLOWAY AVENUE SCI 251 San Francisco, CA 94132
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-01
• Decision Date: 2011-01-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860009406087	K103212	000
00860009406070	K103212	000
00860009406063	K103212	000
00860009406056	K103212	000
00860009406049	K103212	000
00860009406032	K103212	000
00860009406025	K103212	000
00860009406018	K103212	000
00860009406001	K103212	000