FDA.reportPublic FDA data

Mothermed

Primary DI
00818218024059
Brand
Mothermed
Company
Famidoc Technology Co.,Ltd.
Model
ES405
Device description
The product is suitable to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
Published
2016-11-25
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10818218024056PackageGS140In Commercial Distribution
00818218024059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081821802405610818218024056
00818218024059008182180240598182180240590818218024059

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
421343701
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970389630348VeriSmartVSH-B5502025-06-23
06970389630898EQUATEWMTTENS-150J2025-03-04
06970389631130FamidocFDBP-A42023-09-22
06970389632335FamidocFDBP-A32023-09-22
06970389634001FamidocFDES1002023-09-22
06970389634025FamidocFDES1022023-09-22
06970389634032FamidocFDES1032023-09-22
06970389634056FamidocFDES1052023-09-22
06970389634131FamidocFDES1132023-09-22
06970389634155FamidocFDES1152023-09-22
06970389634261FamidocFDES1062023-09-22
06970389638061FamidocFDBP-A12023-09-22
06970389638078FamidocFDBP-A62023-09-22
06970389638085FamidocFDBP-A72023-09-22
06970389638092FamidocFDBP-A82023-09-22
06970389638108FamidocFDBP-A92023-09-22
06970389638122FamidocFDBP-A102023-09-22
06970389638146FamidocFDBP-A132023-09-22
06970389638153FamidocFDBP-A142023-09-22
06970389638160FamidocFDBP-A152023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18