FDA.reportPublic FDA data

Famidoc

Primary DI
00854314007527
Brand
Famidoc
Company
FAMIDOC USA, INC.
Model
FDES108
Device description
Multi-function TENS&EMS Dual pad device
Published
2016-12-29
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
GXYElectrode, Cutaneous
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130723000FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINALFamidoc Technology Co., Ltd.2014-02-07NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854314007524PackageGS140In Commercial Distribution
00854314007527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085431400752410854314007524
00854314007527008543140075278543140075270854314007527

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080370811
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854314007510FamidocFDES1072016-12-29
00854314007114FamidocFDIR-V102016-12-29
00854314007121FamidocFDIR-V222016-12-29
00854314007503FamidocFDES1052016-12-29
00854314007107FamidocFDIR-V22016-12-29
00854314007305FamidocFDTH-V0-12016-12-29
00854314007312FamidocFDTH-V0-3（frog）2016-12-29
00854314007329FamidocFDTH-V0-3（normal）2016-12-29
00854314007336FamidocFDTH-V0-3（rabbit）2016-12-29
00854314007343FamidocFDTH-V0-42016-12-29
00854314007350FamidocFDTH-V0-122016-12-29
00854314007084FAMIDOCFDCO-V112018-05-10
00854314007008FamidocFDCO-V12016-12-29
00854314007015FamidocFDCO-V22016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-29
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-25
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16