Home / 510(k) Clearances / K172887

510(k) K172887

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) by Guangzhou Xinbo Electronic Co., Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
September 21, 2017
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.

  • 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)
  • 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)

Other clearances for product code GXY

  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • 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)