FDA.reportPublic FDA data

reajoy

Primary DI
06973602730719
Brand
reajoy
Company
TOP-RANK HEALTH CARE CO., LTD.
Model
TOPTENS-01
Device description
Transcutaneous Electrical Nerve Stimulator
Published
2025-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210223000Transcutaneous Electrical Nerve StimulatorTop-Rank Health Care Co., Ltd.2021-12-15NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973602730719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973602730719069736027307196973602730719

GMDN Terms#

Term, Definition table
TermDefinition
Transcranial electrical stimulation system, pulsed-currentA noninvasive assembly of electrically-powered devices designed to apply weak, pulsed (not continuous) electrical stimuli to a patient's brain to treat one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction; it may also be intended to induce a state resembling that of chemically-induced anaesthesia. It usually includes an electrical pulse generator with controls to vary the pulse rate, pulse width, and voltage or current, with the current applied via leads and appropriate scalp electrodes. It is intended to be operated by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529504164
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973602730894MEDLOT12W-3527-Q.LA2026-06-08
06973602730849EZ MED SUPPLIESWF2030WF20302026-01-06
06973602730795FyneLookTG01-702025-10-23
06973602730696reajoyTENS806-202025-08-21
06973602730702reajoyTENS806-402025-08-21
06973602730627MedvatMED-USG-TR-CLEAR-22-2PK-A2025-04-23
06973602730610MedvatMED-USG-TR-CLEAR-22-2PK-A2025-03-18
06973602730009LOTFANCY11M-2234-X2020-09-27
06973602730016LOTFANCY11M-2229-S2020-09-27
06973602730023Health Mate Forever12020-09-27
06973602730054Belifu50100-102021-06-15
06973602730047LOTFANCY11N-2261-Y2021-06-15
06973602730061HQX50502021-06-15
06973602730078HQX501002021-06-15
06973602730085Pain ManagementFAF2000FAF20002021-06-15
16973602730051Belifu50100-102021-06-15
16973602730006LOTFANCY11M-2234-X2020-09-27
10697360273013LOTFANCY11M-2229-S2020-09-27
16973602730020Health Mate Forever12020-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28