Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089

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

510(k) Number

K021509 ↗

FDA Product Code

JOW

Models / Variants

5065

5075

5087

5089

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Hygia Health Services Reprocessed Huntleigh Foot Wrap Models Fg 100, Fg 200

  Class II

  FDA 510(k) K012651 Active Cleared 12 Apr 2002

• Hygia Health Services Reprocessed Huntleigh Flowtron Dvt Sleeve Models DVT10, Dvt 20, Dvt 30, Dvt 40

  Class II

  FDA 510(k) K012654 Active Cleared 12 Apr 2002

• Hygia Health Services Reprocessed Lncs Sensors, Models Hhs-1858, Hhs-1862, Hhs-1860 and Hhs-1861

  Class II

  FDA 510(k) K080424 Active Cleared 28 May 2008

• Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-a, Hhs-Max-Al, Hhs-Max-N

  Class II

  FDA 510(k) K041867 Active Cleared 10 Sep 2004

• Hygia Health Services Reprocessed Nu Tech Combo, Model Left Limb and Right Limb

  Class II

  FDA 510(k) K012956 Active Cleared 11 Apr 2002

• Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-SAFB-SM, HHS-SPFB-USA

  Class II

  FDA 510(k) K100523 Active Cleared 4 May 2010

See all devices from Hygia Health Services, Inc. →