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510(k) K202636

Metallic Fabric Electrodes by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
September 11, 2020
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 Guangzhou Xinbo Electronic Co., Ltd.

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  • K202671 — DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) (November 12, 2021)
  • K212948 — Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, (November 1, 2021)
  • K202638 — Pain Therapy Device (July 15, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K190118 — Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) (May 13, 2020)
  • K172887 — XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therap (April 19, 2018)

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