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510(k) K131720

HIVOX SELF ADHESIVE ELECTRODE GEL PADS by Hivox Biotek, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
June 12, 2013
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

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  • K211403 — HIVOX OTC Electrical Stimulator, FT610-B (October 15, 2021)
  • K203574 — HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (March 10, 2021)
  • K192264 — HIVOX Spopad EMS SP-911, SP-921 (November 8, 2019)
  • K190347 — HIVOX OTC Electrical Stimulator (March 15, 2019)
  • K171803 — HIVOX OTC Electrical Stimulator (November 29, 2017)
  • K143737 — EM25 - glute toning device (July 27, 2015)

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