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Data / Medical devices / China / Guangzhou Xinbo Electronic Co., Ltd

Guangzhou Xinbo Electronic Co., Ltd: FDA-registered device maker in guangzhou Guangdong, China, 13 510(k) clearances

Guangzhou Xinbo Electronic Co., Ltd is registered with the FDA (registration 3010097863) in guangzhou Guangdong, China. It lists 18 device types. The FDA files 13 510(k) clearances under its listings, the newest dated May 16, 2024. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Guangzhou Xinbo Electronic Co., Ltd
FDA registration number
3010097863
Address
23 Building, Phase-II Huachuang Industry Park, Panyu, guangzhou Guangdong, China, 511450
Owner or operator
Guangzhou Xinbo Electronic Co., Ltd (10056647)
Roles
Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed
January 3, 2018
Registered through
2026
Brand names listed
Air Wave Cushion, All Day Pain Relief Shirt, Back Pain Relief System Pro, Circulation Promoter, Conductive Carbon Film Electrode, Conductive Silicone Rubber Electrode, Cutaneous Electrode, DR-HO'S Adjustable Pillow and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Traction, Non-PoweredHST1Contract manufacturer, Manufactureraccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Cushion, WheelchairIMP1Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, CutaneousGXY2Complaint file establishment, Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Contract manufactureraccessdata.fda.gov
Media, ElectroconductiveGYB2Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Manufactureraccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Complaint file establishment, Foreign private label distributor, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthosis, LumbarIQE1Contract manufacturer, Manufactureraccessdata.fda.gov
Orthosis, Moldable, Supportive, Skin ProtectiveMNE1Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Contract manufacturer, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Manufactureraccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Manufactureraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Manufactureraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 16, 2024K230711Pain Therapy Device(Model: P.T.S-X)NGXSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
March 11, 2024K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)NGXSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
August 9, 2023K231167Conductive Silicone Rubber ElectrodeGXYSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
August 9, 2023K231164Conductive carbon film electrodeGXYSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
November 12, 2021K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)NUHSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
November 1, 2021K212948Pain 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)NGXSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
August 16, 2021K202636Metallic Fabric ElectrodesGXYSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
July 15, 2021K202638Pain Therapy DeviceNGXSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
November 25, 2020K200402DR-HO'S Electro Therapy Conductive GelGYBSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
May 13, 2020K190118Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)GXYSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
April 19, 2018K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)GXYSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
September 19, 2017K163611Pain Therapy DeviceNUHSubstantially EquivalentGuangzhou Xinbo Electronic Co., Ltd.accessdata.fda.gov
October 9, 2015K151693Dr-Ho's Foot Pad ElectrodeGXYSubstantially EquivalentDrtv Asia, Ltd.accessdata.fda.gov

Compare with other makers

Updated May 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.