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510(k) K192568

Jiajian Self-Adhesive Electrode by Wuxi Jiajian Medical Instrument Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2021
Date Received
September 18, 2019
Clearance Type
Special
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 Wuxi Jiajian Medical Instrument Co., Ltd.

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  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K202861 — Needle Stimulator (August 27, 2021)
  • K202893 — Transcutaneous Electrical Nerve Stimulator (June 18, 2021)
  • K123958 — JIAJIAN POINTOSELECT DIGITAL (October 28, 2013)
  • K130768 — JIAJIAN CMN STIMULATOR (August 16, 2013)
  • K122812 — JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (April 11, 2013)
  • K112288 — JIAJIAN TENS (May 2, 2012)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

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  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
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  • 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)