Karma-Rs, Karma-Fs Wheelchairs

510(k) Number

K884812 ↗

FDA Product Code

ITI

FDA applicant

Orthofab, Inc.

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Oasis

  Class I

  CE/MDR

• Powered Wheelchair

  Class II

  FDA 510(k) K962565 Active Cleared 20 Mar 1997

• Apollo Sterile Blades

  Class I

  FDA 510(k) K852661 Active Cleared 11 Jul 1985

• Orthofab Wheelchair Astra (Folding Manual Wheelchair)

  Class I

  FDA 510(k) K950904 Active Cleared 5 Apr 1995

• Orthofab Wheelchair Ultima (Rigid Frame Manual Wheelchair)

  Class I

  FDA 510(k) K950903 Active Cleared 5 Apr 1995

• Digikit Nonpneumatic Tourniquet

  Class I

  FDA 510(k) K860095 Active Cleared 24 Jan 1986

See all devices from Orthofab inc. →