FDA.reportPublic FDA data

E-Stim III

Primary DI
14897076723536
Brand
E-Stim III
Company
TENS PLUS INDUSTRIAL COMPANY
Model
ED3981
Catalog number
ED3981
Device description
The E-Stim III® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions.
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050435000E-STIM IILhasa Oms, Inc.2005-09-06GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897076723536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489707672353614897076723536

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
663211978
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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14897076721495PULSE PAD LARGE SIZEPulse.Pad.L2022-11-14
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14897076720146GB-3GD5208GD52082021-03-30
14897076721457Lion.Warm.XLGY53362023-06-05
14897076721655Multi.D.1.5MD28022023-06-05
14897076721815Moxa.Bx.BamSGY53372023-06-05
14897076721822Moxa.Bx.BamLGY53382023-06-05
14897076721853PistolDY09502023-06-05
14897076721860Pistol.LongDY21112023-06-05
14897076721877Ins.MP.SMD26112023-06-05
14897076721884Ins.MP.MMD26122023-06-05
14897076721891Ins.MP.LMD26132023-06-05
14897076722263Guasha.SBY26082023-06-05
14897076722270Guasha.MBY26092023-06-05
14897076722287Guasha.LBY26102023-06-05
14897076722454Tiger.Warm.SGY53672023-06-05
14897076722546Tiger.Warm.SGY53672023-06-05
14897076722577Bio.N.2MD28632023-06-05
14897076722614Ring.FingerMY26022023-06-05
14897076722621Tsubo.VibMY27502023-06-05

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Primary DI, Brand, Company table
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