Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008048783

FEI Number

3008048783

Entity Name

DRTV Asia LTD

City/State/Country

Panyu GuangZhou Guangdong, CN

Establishment Address

Building 23, Phase II Huachuang Industry Park, Panyu GuangZhou Guangdong 511450, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DRTV Asia Ltd (Owner Number: 10030634)

Owner / Operator Contact Address

Building 23, Phase II Huachuang Industry Park, Panyu GuangZhou, CN-NOTA 511450, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151693

PMA Number

N/A

All Registered Proprietary Names

Neck Comforter Circulation Sleeve for knee and calf, Back Belt, Therapy & Support Band, Knee Brace, Leg Rest, Back Pain Relief Shirt Pain Therapy device (Model P.T.S- Vi, P.T.S-Vii) SM TENS & PMS Conductive Carbon Film Electrode DR-HO'S Heat Therapy Belt Magic Heat Pad DR-HO'S Adjustable Pillow Conductive Silicon Rubber Electrode DR-HO'S Shiatsu Neck & Shoulder Massager MotionCiser Motionciser Exercise Bands Diabetic Insoles DR-HO'S Air Orthotics Boomcare Infrared Ear & Forehead Thermometer DR-HO's Shoulder Support, DR-HO's Wrist Support, DR-HO's Elbow Compression Support, DR-HO's Knee Compression Support, DR-HO's Ankle Compression Support, DR-HO's Foot and Ankle Compression support, DR-HO's Calf Compression Support DR-HO'S Perfect Back Rest DR-HO's Back Support Belt Neck Therapy Pro Fabric Electrodes Neck Pain Pro DR-HO'S Circulation Promoter Pro TENS Pain Therapy System Models: P.T.S-III Air Wave Cushion Jiajian Self Adhesive Electrode DR-HO'S Pain Therapy 4-Pad TENS DR-HO'S Circulation Promoter TENS DR-HO'S Pain Relief TENS Equate Pain Therapy TENS Neck Pain Pro Neck Therapy Pro TENS Triple Action Back Belt TENS DR-HO'S Triple Action Back Belt Circulation Promoter XP TENS DR-HO'S Neck Pain Pro Dr-Ho's Foot Pad Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2009-10-26
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-12-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-12-06
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2024-12-06
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-12-06
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-12-06
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-12-06
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2016-07-13
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2016-07-13
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-12-06
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2013-04-08
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2023-07-18
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-12-06
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2012-07-10
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2012-05-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-07-22
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-08-25
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2014-04-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2018-09-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-12-15
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-12-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-12-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2021-12-15
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2021-12-15
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2014-12-29
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-04-07
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2018-02-15
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2018-02-15
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2018-02-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2015-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

DRTV Asia Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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2921578	MIZUHO ORTHOPEDIC SYSTEMS, INC.	UNION CITY, CA, US
8010100	MEDITRAC MEDICAL EQUIPMENT LTD.	TEL-AVIV Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008048783. Last updated year: 2026. Please use registration number 3008048783 when referencing this establishment in official correspondence.