FDA.reportPublic FDA data

Equate

Primary DI
00194346404155
Brand
Equate
Company
WAL-MART STORES, INC.
Model
EM47
Device description
Equate Tens & Heat Therapy
Published
2026-05-01
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194346404155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194346404155001943464041551943464041550194346404155

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
051957769
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28
00194346699421EquateFBL7100072026-04-17
00194346219230ReliOn™ Premier Classic Meter784001N/A2025-02-11
00194346219254ReliOn™ Premier Blood Glucose Test Strips780025N/A2025-02-11
00194346219261ReliOn™ Premier Blood Glucose Test Strips780050 / 780100N/A2025-02-11
00681131169776ReliOn™ Premier Blood Glucose Test Strips780050 / 7801002017-11-14
00681131280624ReliOn™ Premier Classic Meter7840012019-08-21
00681131285742ReliOn™ Premier Blood Glucose Test Strips7800252019-08-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00851530007645AvazziaAVAZZIA INCNUH2026-03-31
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
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00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NUH2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNUH2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NUH2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNUH2025-08-15
00850073128107AVCOOADP HEALTH LIMITEDNUH2025-07-02
00850073128091AVCOOADP HEALTH LIMITEDNUH2025-05-26
00810038637365easy@Home TENS AND MUSCLE STIMULATOREASY HEALTHCARE CORPORATIONNUH2025-04-17