FDA.reportPublic FDA data

MASTOGO

Primary DI
06971712726783
Brand
MASTOGO
Company
Hong Qiangxing (Shen Zhen) Electronics Limited
Model
TENS
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121719000
K190009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121719000SM TENS & PMSHong Qiangxing (Shenzhen) Electronics Limited2013-05-10NGX
K190009000Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)Hong Qiangxing (Shenzhen) Electronics Limited2019-12-02NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971712726790PrimaryGS10
06971712726783Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971712726790069717127267906971712726790
06971712726783069717127267836971712726783

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421286946
Device count
36
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971712725922DOMASSM90672026-10-13
06971712729593KorriSM91162024-11-19
06971712720583Smart-Wave Knee RehabSM90752025-08-05
06971712729975SeanWireless TENS & EMS2016-09-12
06971712727964mastogoSM91872024-11-18
06971712726417NourishnestSM91162026-07-29
06971712725908MASTOGOSunmas TENS & PMS2026-07-25
06971712725366DOMASSM95552023-06-06
06971712722846DOMASTENS2022-11-15
06971712722860ZQQYSM91162022-11-30
06971712725939SalitySM91872023-09-14
06971712722426MASTOGOSM91872022-09-17
06971712725359DOMASSM90752026-07-09
06971712722693DOMASSM90752026-07-09
06971712727636ONENTECHSM91162026-07-03
06971712722709DOMASTENS2022-10-20
06971712722075MASTOGOSunmas TENS & PMS2026-06-02
06971712726943MASTOGOPain Therapy Device2026-05-30
06971712722990SalitySunmas TENS & PMS2026-05-28
06971712727704YUN MANSIONWireless TENS & EMS2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
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 LimitedGZJ2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
08032625829843NerveOTXDOMINO SRLGZJ2026-07-28
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
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.GZJ2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01