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510(k) K050156

WHS-1000 WOUND HEALING SYSTEM by Iyia Technologies, Inc. — Product Code KPJ

K050156 is an FDA 510(k) premarket notification submitted by Iyia Technologies, Inc. for the device "WHS-1000 WOUND HEALING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 17, 2005. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2005
Date Received
January 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

Other clearances for product code KPJ

  • K250188 — Wound Treatment System (VHT-200) (March 10, 2025)
  • K212121 — VHT-200 Wound Treatment System (March 23, 2023)
  • K190742 — EPIFLO-28 (December 13, 2019)
  • K112634 — NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (July 3, 2012)
  • K120764 — EPIFLO(R) (April 27, 2012)
  • K090681 — TANSCU O2 (August 12, 2009)
  • K080966 — HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM (August 6, 2008)
  • K023456 — OXYBOX SYSTEM (February 24, 2003)
  • K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (December 17, 2002)
  • K020466 — HEC 1000 (May 8, 2002)

FDA data resources