FDA.reportPublic FDA data

YUN MANSION

Primary DI
06971712727704
Brand
YUN MANSION
Company
Hong Qiangxing (Shen Zhen) Electronics Limited
Model
Wireless TENS & EMS
Published
2026-05-26
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233067000Wireless TENS & EMS (Model SM9110,SM9113,SM9116)Chongqing Rob Linka Science and Technology Co., Ltd.2024-07-19NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971712727701PackageGS140In Commercial Distribution
06971712727704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697171272770116971712727701
06971712727704069717127277046971712727704

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Regulatory Flags#

DUNS number
421286946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
06971712726950MASTOGOSunmas TENS & PMS2024-06-03
06971712727988mastogoSunmas TENS & PMS2024-11-20
06971712723621BELIFUSM90552025-08-05
16971712724502LILASM90672026-03-03
16971712720139KINGPAVONINISM91162026-01-30
06971712723928VITERARED THERAPY2026-01-30
06971712723645NURSALSM90752025-08-05
06971712722082CriterionTENS2022-08-03
06971712723027DOMASSM95872022-12-02
06971712725915DOMASSM9065N2023-09-19
06971712726387CQJCTCLSM91262024-01-19
06971712726400CQJCTCLSM91262024-01-20
06971712722587CESLIFFSM91262022-10-15
16971712720122ProcomfortSM90752025-12-10
16971712725110DOMASSM91872023-04-20
16971712724656BelifuSM91262022-12-25
06971712720057NEOCARBONSM90752025-08-31
16971712725073Copper lifeSM91162025-08-27
06971712720248NEOCARBONSM90752020-07-23
06971712727360DotsGeekPain Therapy Device SM90752024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988466AUVONUAN HEALTHCARE LIMITEDNGX2026-05-24
00850080988466AUVONUAN HEALTHCARE LIMITEDNUH2026-05-24
10850080988142AUVONUAN HEALTHCARE LIMITEDNGX2026-03-23
10850080988135AUVONUAN HEALTHCARE LIMITEDNGX2026-03-19
06932307410418JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.NUH2026-03-04
16971712724502LILAHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-03-03
00714905710024Fab StimCOMPASS HEALTH BRANDS CORP.NUH2026-02-06
07290018152164Pure ImpactSOFWAVE MEDICAL LTDNGX2026-02-01
16973810850435BelifuShenzhen Jian Feng Electronic Technology Co., Ltd.NGX2026-01-29
08059916140005Limfa Therapy System (Limfa Therapy)EYWA SRLNGX2026-01-29
00199874173993Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-01-22
06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2026-01-21
00850016867407Pixie CupPixie Cup LLCNUH2026-01-09
06950940802810N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-19
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-12-17
06950940802773N/AShenzhen Osto Technology Co.,Ltd.NGX2025-12-10
16971712720122ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-12-10
00810093080786PainPod Hi-Dow International IncorporatedNUH2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNUH2025-12-09
10860015112405TENSnet 3MTCLINICAL HEALTH SERVICES, INC.NGX2025-12-05
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
00850022650543Motive Lower Back SystemMotive Health, Inc.NGX2025-11-28
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-22
10850073128180AVCOOADP HEALTH LIMITEDNUH2025-09-19
10850073128197AVCOOADP HEALTH LIMITEDNUH2025-09-19
16971292004117AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-19
10850073128166AVCOOADP HEALTH LIMITEDNUH2025-09-18