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510(k) K200402

DR-HO'S Electro Therapy Conductive Gel by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GYB

K200402 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "DR-HO'S Electro Therapy Conductive Gel". The FDA issued a decision of Substantially Equivalent on November 25, 2020. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2020
Date Received
February 19, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Guangzhou Xinbo Electronic Co., Ltd.

  • K230711 — Pain Therapy Device(Model: P.T.S-X) (May 16, 2024)
  • K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) (March 11, 2024)
  • K231167 — Conductive Silicone Rubber Electrode (August 9, 2023)
  • K231164 — Conductive carbon film electrode (August 9, 2023)
  • 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)
  • K202636 — Metallic Fabric Electrodes (August 16, 2021)
  • K202638 — Pain Therapy Device (July 15, 2021)
  • 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)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)
  • K190050 — Tech Dots - Adhesive and conductive gel (July 19, 2019)

FDA data resources