Digikit Nonpneumatic Tourniquet

510(k) Number

K860095 ↗

FDA Product Code

KCY

FDA applicant

Orthofab, Inc.

Device Class

Class I

Regulation

21 CFR Part 878.5910

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Oasis

  Class I

  CE/MDR

• Karma-Rs, Karma-Fs Wheelchairs

  Class II

  FDA 510(k) K884812 Active Cleared 27 Dec 1988

• 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

See all devices from Orthofab inc. →