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510(k) K864032

EM TENS WINDOW ELECTRODES by Electromed Intl., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1986
Date Received
October 15, 1986
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 Electromed Intl., Ltd.

  • K003688 — VIEW READING STATION (January 22, 2001)
  • K000474 — VIEW NT (April 19, 2000)
  • K990759 — VIEW COM (April 15, 1999)
  • K974255 — CD-R STATION AND VRS-2000 (January 27, 1998)
  • K971176 — VIEW ARCHIVING STATION (September 3, 1997)
  • K950694 — COMPACT-X (March 31, 1995)
  • K880050 — EDEC 60R (February 29, 1988)
  • K875341 — EDEC 60 R/F (February 1, 1988)
  • K875342 — EDEC 90C (January 29, 1988)
  • K871145 — EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR (March 31, 1987)

Other clearances for product code GXY

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  • 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)