Home / 510(k) Clearances / K921189

510(k) K921189

THERMA-H by Zewa AG — Product Code LKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1992
Date Received
March 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Zewa AG

  • K041491 — ZEWA MFM-007 BLOOD PRESSURE MONITOR (September 20, 2004)
  • K024077 — DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR (March 10, 2003)
  • K952765 — DELWA-STAR PACIFIER THERMOMETER (October 13, 1995)

Other clearances for product code LKX

  • K172358 — Instalief (January 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (April 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (September 30, 2005)
  • K012746 — ICE BATON (November 14, 2001)
  • K981428 — ANU ICE (July 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (August 7, 1995)
  • K905276 — THERMA-H (November 7, 1991)
  • K883984 — HEMORX COLD PACK (December 22, 1988)