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510(k) K010543

KM-30 TENS ELECTRODE by Katecho, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2001
Date Received
February 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Katecho, Inc.

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (December 14, 2000)
  • K002806 — K-DEFIB/PACE, MODEL KDP-60A (November 21, 2000)
  • K000870 — KM-10 TENS ELECTRODE (November 7, 2000)
  • K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (February 3, 2000)
  • K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (August 23, 1999)
  • K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (December 9, 1998)
  • K954504 — K-DEFIB/PACE PEDIATRIC ELECTRODE (November 17, 1995)
  • K934692 — K-DEFIB/PACE PEDIATRIC ELECTRODE (January 24, 1995)
  • K940801 — K-KLIP (August 3, 1994)

Other clearances for product code GXY

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  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)