GIZMO

Wheelchair, Mechanical

FREEDOM DESIGNS, INC.

The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for Gizmo.

Pre-market Notification Details

• Device ID: K023574
• 510k Number: K023574
• Device Name: GIZMO
• Classification: Wheelchair, Mechanical
• Applicant: FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065
• Contact: Ginny S Maloco
• Correspondent: Ginny S Maloco; FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-24
• Decision Date: 2002-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841447101239	K023574	000