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510(k) K861593

TOPICAL HYPERBARIC OXYGEN CHAMBER by Stephenson Industries, Inc. — Product Code KPJ

K861593 is an FDA 510(k) premarket notification submitted by Stephenson Industries, Inc. for the device "TOPICAL HYPERBARIC OXYGEN CHAMBER". The FDA issued a decision of Substantially Equivalent on May 12, 1986. The device falls under product code KPJ (Chamber, Oxygen, Topical, Extremity), a Class II device regulated under 21 CFR 878.5650. Stephenson Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1986
Date Received
April 29, 1986
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 by Stephenson Industries, Inc.

  • K963777 — HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 (July 28, 1997)
  • K861101 — THE NEW FLEXIBLE COLLAPSIBLE CHAMBER (May 6, 1986)
  • K853971 — REGULATOR-INHALATOR SYSTEM (December 9, 1985)

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)
  • 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)

FDA data resources