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510(k) K080966

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM by Aoti , Ltd. — Product Code KPJ

K080966 is an FDA 510(k) premarket notification submitted by Aoti , Ltd. for the device "HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on August 6, 2008. 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
August 6, 2008
Date Received
April 4, 2008
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)
  • K050156 — WHS-1000 WOUND HEALING SYSTEM (June 17, 2005)
  • 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