FDA.reportPublic FDA data

Easy@Home TENS Pain Relief Device

Primary DI
00810038630113
Brand
Easy@Home TENS Pain Relief Device
Company
EASY HEALTHCARE CORPORATION
Model
EHE009
Published
2020-02-03
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
10810038630110PackageGS120In Commercial Distribution
00810038630113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003863011010810038630110
00810038630113008100386301138100386301130810038630113

GMDN Terms#

Term, Definition table
TermDefinition
Static magnetic therapeutic clothing/jewelryA body-worn magnetized metallic device intended to be used in the home to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief from aches, pain or tension (e.g., due to arthritis, sciatica, whiplash, sports injuries, muscle soreness/stiffness, dysmenorrhea, menopause), psycho-emotional stress, and/or sleep ailments. It is available in a variety of forms (e.g., clothing, belt, insole, bracelet, necklace, ring, plate, disk, pad, mask) and may be attached to clothing or applied directly to the skin with an adhesive plaster. It is not designed as an orthosis (i.e. does not provide therapeutic body support). This is a reusable device.

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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