FDA.reportPublic FDA data

No

Primary DI
06973810850421
Brand
No
Company
Shenzhen Jian Feng Electronic Technology Co., Ltd.
Model
FM-B2501
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223825000Tens & Ems DeviceShenzhen Jian Feng Electronic Technology Co., Ltd.2023-05-09NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16973810850428PackageGS130In Commercial Distribution
26973810850425PackageGS140In Commercial Distribution
36973810850422PackageGS160In Commercial Distribution
06973810850421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697381085042816973810850428
2697381085042526973810850425
3697381085042236973810850422
06973810850421069738108504216973810850421

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
560082555
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973810850445BelifuSM91262026-04-08
06973810850438BelifuSM91262026-01-29
16973810850435BelifuSM91262026-01-29
06973810850414NoFM-B24042025-03-11
16973810850411NoFM-B24042025-03-11
06973810850278NoTU11302024-06-26
06973810850308NoTU11302024-07-05
06973810850322NoTA2224C2024-07-16
06973810850377NoAS80192024-09-04
06973810850193NoAS90202024-05-30
06973810850209NoAS90202024-05-30
06973810850216NoAS90202024-05-30
06973810850223NoAS90202024-05-30
06973810850247NoTU22242024-05-30
06973810850285NoTA22242024-06-27
06973810850292NoTA22242024-06-27
06973810850384AVCOOTU24242024-12-10
06973810850407AVCOOTA2224C2024-12-13
16973810850381AVCOOTU24242024-12-10
16973810850404AVCOOTA2224C2024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNGX2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNGX2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNGX2025-08-25
00850073128121AVCOOADP HEALTH LIMITEDNGX2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00850073128107AVCOOADP HEALTH LIMITEDNGX2025-07-02
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128084AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03