Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DR-HO'S Electro Therapy Conductive Gel

K-Number: K200402 · 2020-11-25

ApplicantGuangzhou Xinbo Electronic Co., Ltd.
Decision Date2020-11-25
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DR-HO'S Electro Therapy Conductive Gel is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K200402. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DR-HO'S Electro Therapy Conductive Gel?

DR-HO'S Electro Therapy Conductive Gel is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K200402.

When did DR-HO'S Electro Therapy Conductive Gel receive FDA 510(k) clearance?

DR-HO'S Electro Therapy Conductive Gel received FDA 510(k) clearance on 2020-11-25, under 510(k) number K200402.

Who is the listed applicant for DR-HO'S Electro Therapy Conductive Gel?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR-HO'S Electro Therapy Conductive Gel?

The FDA product code for DR-HO'S Electro Therapy Conductive Gel is GYB.

Other records listing Guangzhou Xinbo Electronic Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231167Conductive Silicone Rubber ElectrodeK231164Conductive carbon film electrodeK202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)K212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

View all 12 devices →

Related Devices (Code: GYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑