Pointer-Plus

Primary DI
14897076720047
Brand
Pointer-Plus
Company
TENS PLUS INDUSTRIAL COMPANY
Model
ED3332
Catalog number
ED3332
Device description
"Pointer-Plus - Locator/Stim is a complete clinic in your hands. Modern, hand held, 6.5"" long unit offers accurate acupuncture point stimulation with adjustable intensity dial. The pulse frequency is fixed at 10 Hz. The grounding circuit is made by holding the metal plate on the side of the unit or with the hand grounding pole. Accessories include 2 probe tips (ear 2 mm 0.08"" and body 4 mm 0.16""), hand grounding pole with attached wire, 9 volt battery, carrying case, 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
K060508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060508000POINTER PLUSLhasa Oms, Inc.2006-06-19GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34897076720041PackageGS150In Commercial Distribution
14897076720047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3489707672004134897076720041
1489707672004714897076720047

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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