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510(k) K210383

Wrap Accessory Electrodes by Hi-Dow International, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2021
Date Received
February 9, 2021
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 Hi-Dow International, Inc.

  • K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (January 19, 2024)
  • K202337 — Pulsed electromagnetic field wrap (December 15, 2020)
  • K190617 — Wrap accessory electrodes (July 2, 2019)
  • K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N) (August 4, 2017)
  • K102598 — HI-DOW-XP (May 13, 2011)

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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)