Home / 510(k) Clearances / K960756

510(k) K960756

LIFETECH CASSETTE by Lifetech Systems, Inc. — Product Code KPJ

K960756 is an FDA 510(k) premarket notification submitted by Lifetech Systems, Inc. for the device "LIFETECH CASSETTE". The FDA issued a decision of Substantially Equivalent on August 29, 1997. 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 29, 1997
Date Received
February 23, 1996
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)
  • 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