Scm-3 and Accessories

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914921 ↗

FDA Product Code

IKY

Device Class

Class I

Regulation

21 CFR Part 880.5150

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900

  Class II

  FDA 510(k) K100585 Active Cleared 20 Jan 2011

• Sequential Pressure Cuff

  Class II

  FDA 510(k) K771083 Active Cleared 21 Jul 1977

• Sof. Press Epc 51 System

  Class II

  FDA 510(k) K963067 Active Cleared 28 Jan 1997

• T-Pump Localized Temperature Therapy Pump

  Class II

  FDA 510(k) K073675 Active Cleared 8 May 2008

• T-Pump, Temperature - Therapy Pump

  Class II

  FDA 510(k) K760804 Active Cleared 15 Oct 1976

• Lifestyle Sof. Care Gel Chair Cushion

  Class I

  FDA 510(k) K882012 Active Cleared 23 May 1988

See all devices from Gaymar Industries, Inc. →