Medical Device Manufacturer · US , Cottage Grove , MN

Orthofab, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1985

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orthofab, Inc. Physical Medicine ✕

5 devices

1-5 of 5

Cleared Mar 20, 1997

POWERED WHEELCHAIR

Physical Medicine · 262d

Cleared May 07, 1996

ORTHOFAB WHEELCHAIR

Physical Medicine · 330d

Cleared Apr 05, 1995

ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)

Physical Medicine · 36d

Cleared Apr 05, 1995

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)

Physical Medicine · 36d

Cleared Dec 27, 1988

KARMA-RS, KARMA-FS WHEELCHAIRS

Physical Medicine · 40d