E-Stim II

Primary DI
14897076720030
Brand
E-Stim II
Company
TENS PLUS INDUSTRIAL COMPANY
Model
ED3922
Catalog number
ED3922
Device description
The E-Stim II® 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
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
34897076720034PackageGS130In Commercial Distribution
14897076720030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3489707672003434897076720034
1489707672003014897076720030

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-722-8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
663211978
Device count
1
Serial number
true

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