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510(k) K190617

Wrap accessory electrodes by Hi-Dow International, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2019
Date Received
March 11, 2019
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)
  • K210383 — Wrap Accessory Electrodes (November 12, 2021)
  • K202337 — Pulsed electromagnetic field wrap (December 15, 2020)
  • K163393 — Hi-Dow Wireless TENS/EMS System (Model HD-5N) (August 4, 2017)
  • K102598 — HI-DOW-XP (May 13, 2011)

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