MANUAL RIGID MOBILITY WHEELCHAIR


Device Classification Name

wheelchair, mechanical

510(k) Number K080270
Device Name MANUAL RIGID MOBILITY WHEELCHAIR
Applicant
FREEDOM DESIGNS, INC.
2241 madera rd.
simi valley, 
CA 
93065

Applicant Contact bob gardner
Correspondent
FREEDOM DESIGNS, INC.
2241 madera rd.
simi valley, 
CA 
93065

Correspodent Contact bob gardner
Regulation Number 890.3850
Classification Product Code
IOR  
Date Received 02/01/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No