Alba Health Pas Wrap System

• • Terminated Z-0183-2012 FDA Unclassified (pre-2012) ·initiated 12 Oct 2011

  The wrap portion of the device was tearing at the seam.

510(k) Number

K961405 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Albahealth C.A.L.M. Sleeve, Model 59001

  Class II

  FDA 510(k) K020592 Active Cleared 3 Apr 2002

• Compression Devices, Limb

  Class II

  FDA 510(k) K781964 Active Cleared 12 Dec 1978

• Sterile Orthopedic Stockinette

  Class I

  FDA 510(k) K780547 Active Cleared 10 Apr 1978

• Sterile Impervious Orthopedic Stockin

  Class II

  FDA 510(k) K792357 Active Cleared 18 Dec 1979

• Tubular Dressing Retainer

  Class I

  FDA 510(k) K780570 Active Cleared 19 Apr 1978

• Heel/Elbow Protector

  Class I

  FDA 510(k) K771913 Active Cleared 15 Nov 1977

See all devices from Alba-Waldensian, Inc. →