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Data / Medical devices / China / DRTV Asia LTD

DRTV Asia LTD: FDA-registered device maker in Panyu GuangZhou Guangdong, China, 14 510(k) clearances

DRTV Asia LTD is registered with the FDA (registration 3008048783) in Panyu GuangZhou Guangdong, China. It lists 16 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 16, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch DRTV Asia LTD
FDA registration number
3008048783
Address
Building 23 Phase II Huachuang Industry Park, Panyu GuangZhou Guangdong, China, 511450
Owner or operator
DRTV Asia Ltd (10030634)
Roles
Exporter to the US, Foreign private label distributor, Specification developer
First device listed
October 26, 2009
Registered through
2026
Brand names listed
Air Wave Cushion, Boomcare Infrared Ear & Forehead Thermometer, Circulation Promoter XP TENS, Circulation Sleeve for knee and calf, Back Belt, Therapy & Support Band, Knee Brace, Leg Rest, Back Pain Relief Shirt, Conductive Carbon Film Electrode, Conductive Silicon Rubber Electrode, DR-HO'S Adjustable Pillow, DR-HO'S Air Orthotics and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Traction, Non-PoweredHST1Exporter to the USaccessdata.fda.gov
Component, Traction, Non-InvasiveKQZ1Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Cushion, WheelchairIMP1Exporter to the USaccessdata.fda.gov
Electrode, CutaneousGXY2Exporter to the USaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Foreign private label distributoraccessdata.fda.gov
Orthosis, CervicalIQK1Specification developeraccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Exporter to the USaccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the USaccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Exporter to the USaccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Exporter to the USaccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Exporter to the USaccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Exporter to the USaccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Exporter to the USaccessdata.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 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
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 3, 2019K182597Infrared thermometerFLLSubstantially EquivalentShenzhen Pango 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
May 10, 2013K121719SM TENS & PMSNGXSubstantially EquivalentHong Qiangxing (Shenzhen) Electronics Limitedaccessdata.fda.gov
June 23, 2009K090198JIAJIAN SELF-ADHESIVE ELECTRODEGXYSubstantially EquivalentWuxi Jiajian Medical Instrument Co., Ltd.accessdata.fda.gov

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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.