FDA.reportPublic FDA data

Nuemedics

Primary DI
06971712726080
Brand
Nuemedics
Company
Hong Qiangxing (Shen Zhen) Electronics Limited
Model
SM TENS&PMS SM9089
Device description
BLACK
Published
2023-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121719000
K220152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121719000SM TENS & PMSHong Qiangxing (Shenzhen) Electronics Limited2013-05-10NGX
K220152000TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)Hong Qiangxing (Shenzhen) Electronics Limited2022-04-19NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971712726097PrimaryGS10
06971712726080Unit of UseGS10
16971712726087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971712726097069717127260976971712726097
06971712726080069717127260806971712726080
1697171272608716971712726087

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
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971712722990SalitySunmas TENS & PMS2026-05-28
06971712727704YUN MANSIONWireless TENS & EMS2026-05-26
06971712727698BLEASEWireless TENS & EMS2016-12-07
06971712727087Dr. O SolutionsTENS &PMS2026-05-18
06971712727094auraTENS&EMS2024-06-25
06971712726950MASTOGOSunmas TENS & PMS2024-06-03
06971712727988mastogoSunmas TENS & PMS2024-11-20
06971712723621BELIFUSM90552025-08-05
06971712722587CESLIFFSM90552022-10-15
16971712724502LILASM90672026-03-03
06971712724505LILASM90672026-03-03
06971712720132KINGPAVONINISM91162026-01-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-03-31
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-03-31
16977159460065versatone-xtGymmax Technology (Shenzhen) Co., Ltd.NGX2024-12-19
16977159460072versatoneGymmax Technology (Shenzhen) Co., Ltd.NGX2024-12-19
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00023601272027TENS 7000Drive Devilbiss HealthcareNUH2024-11-22
00023601272027TENS 7000Drive Devilbiss HealthcareNGX2024-11-22