FDA.reportPublic FDA data

HealthmateForever

Primary DI
00817856020263
Brand
HealthmateForever
Company
HEALTHMATE INTERNATIONAL,LLC
Model
HM8ML Blue
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817856020260PackageGS172Not in Commercial Distribution
00817856020263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081785602026010817856020260
00817856020263008178560202638178560202630817856020263

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
014593382
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817856020003HealthmateForeverYK15AB White2016-09-16
00817856020027HealthmateForeverPro12ab Black2016-09-18
00817856020034HealthmateForeverPro12ab Silver2016-09-18
00817856020058HealthmateForeverNK10GL Black2016-09-18
00817856020065HealthmateForeverNK10AB Black2016-09-18
00817856020072HealthmateForeverNK10AB Silver2016-09-18
00817856020089HealthmateForeverHM8ML Black2016-10-11
00817856020096HealthmateForeverBM8ML Black2016-10-11
00817856020119HealthmateForeverHM8GL Black2018-04-25
00817856020140HealthmateForeverPro6abs Black2016-10-11
00817856020225HealthmateForeverHM8GL Silver2017-01-13
00817856020232HealthmateForeverHM8GAB Silver2017-01-13
00817856020249HealthmateForeverHM8GAB Black2017-01-13
00817856020256HealthmateForeverHM8ML Silver2017-01-13
00817856020270HealthmateForeverPro15ab Black2017-01-13
00817856020287HealthmateForeverPro15ab Silver2017-01-13
00817856020294HealthmateForeverPro18ab Silver2017-01-13
00817856020300HealthmateForeverPro18ab Black2017-01-13
00817856020317HealthmateForeverHM15GAB Black2017-01-13
00817856020324HealthmateForeverWI92017-01-13

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
00850073128190AVCOOADP 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