FDA.reportPublic FDA data

Easy@Home Electronic TENS Pulse Massager

Primary DI
00850253007130
Brand
Easy@Home Electronic TENS Pulse Massager
Company
EASY HEALTHCARE CORPORATION
Model
EHE010
Published
2016-08-05
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
K131921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131921000ELECTRONIC PULSE STIMULATORShenzhen Jingkehui Electronic Co.., Ltd.2013-11-15NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850253007137PackageGS120In Commercial Distribution
00850253007130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085025300713710850253007137
00850253007130008502530071308502530071300850253007130

GMDN Terms#

Term, Definition table
TermDefinition
Pain-relief static magnetA magnetized metal device designed to be worn on any part of the body (non-dedicated) and intended to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief of body aches and pains (e.g., from arthritis, sciatica, whiplash, spinal injuries, sports injuries, and muscle soreness/stiffness). It is typically encased in a synthetic material (plastic) or covered with gold (Au) to minimize skin allergies, and may be attached to clothing or applied directly to the skin with an adhesive plaster at the site of the pain. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080278407
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038637327Easy@Home Marijuana Test Cup(1 test kit)ECTH4-114A3ECTH4-114A3-12026-02-12
00810038638072Easy@Home FSH Urine Test (5 Tests)EFS1-MAEFS1-MA-52025-10-06
00810038638157Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
00810038638850Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
00810038637150easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
00810038638041easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
00810038638867Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17

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Primary DI, Brand, Company table
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03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
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