FDA.reportPublic FDA data

Numiere

Primary DI
06971712722976
Brand
Numiere
Company
Hong Qiangxing (Shen Zhen) Electronics Limited
Model
SM9916
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971712722976PrimaryGS10
16971712722973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971712722976069717127229766971712722976
1697171272297316971712722973

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.

Regulatory Flags#

DUNS number
421286946
Device count
12
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
16971712720122ProcomfortSM90752025-12-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977168990013NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
06977168990129NuonShenzhen Nuon Medical Equipment Co., Ltd.NFO2026-04-21
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00850021950088Medi Lift YA-MAN LTD.NFO2026-02-19
00810075943276NuFACENufaceNFO2026-01-27
00810075944570NuFACENufaceNFO2026-01-27
00850021950071Medi Lift YA-MAN LTD.NFO2026-01-14
06979082450000FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450017FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
06979082450024FynelookShenzhen Dachi communication Co.,LtdNFO2025-12-02
00851367006217ZIIP BeautyZIIP, INC.NFO2025-09-30
05391540830871Préime DermaFacial EMA AESTHETICS LIMITEDNFO2025-09-15
00851367006163ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006170ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006187ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006194ZIIP BeautyZIIP, INC.NFO2025-08-07
00851367006200ZIIP BeautyZIIP, INC.NFO2025-08-07
05391540830840Préime DermaFacialEMA AESTHETICS LIMITEDNFO2025-08-07
00817076014516bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014523bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
00817076014530bt-sculpt GEN2MICRO CURRENT TECHNOLOGY, INC.NFO2025-08-06
08908008085499Syrma Johari MedTech LimitedSYRMA JOHARI MEDTECH LIMITEDNFO2025-07-08
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