SOLUTION

Wheelchair, Mechanical

FREEDOM DESIGNS, INC.

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

Pre-market Notification Details

• Device ID: K944970
• 510k Number: K944970
• Device Name: SOLUTION
• Classification: Wheelchair, Mechanical
• Applicant: FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065
• Contact: Ginny Maloco
• Correspondent: Ginny 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: 1994-10-11
• Decision Date: 1994-12-13