AURAWAVE

Primary DI
00628055644002
Brand
AURAWAVE
Company
ENDURANCE THERAPEUTICS INC.
Model
AWDD
Device description
T.E.N.S. Device ; Pain Relief Therapy Kit.
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055644002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055644002006280556440026280556440020628055644002

GMDN Terms#

Term, Definition table
TermDefinition
Arthritis TENS systemAn assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of an external electric current generator and electrodes that are placed on the skin near a joint(s) to provide the electrical stimulus to the painful area. 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 routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.358.7145support@pmafulfillment.com

Regulatory Flags#

DUNS number
963843318
Device count
1
Kit
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
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00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
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