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510(k) K941389

EMPI TAPE PATCHES by Empi — Product Code KGX

K941389 is an FDA 510(k) premarket notification submitted by Empi for the device "EMPI TAPE PATCHES". The FDA issued a decision of Substantially Equivalent on August 23, 1994. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Empi has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1994
Date Received
March 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Empi

  • K093324 — EMPI CONTINUUM (March 5, 2010)
  • K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (June 5, 2009)
  • K072946 — HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM (November 16, 2007)
  • K070427 — DUPEL TRANSPORT IONTOPHORESIS SYSTEM (May 14, 2007)
  • K061650 — SELECT TENS, MODEL 4600S (January 22, 2007)
  • K041920 — INFINITY PLUS ELECTROTHERAPY SYSTEM (January 21, 2005)
  • K042057 — INFINITY ELECTROTHERAPY SYSTEM (December 17, 2004)
  • K030395 — EMPI ACTION PATCH IONTOPHORESIS SYSTEM (April 8, 2003)
  • K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM (June 18, 2002)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources