AXUS ES-5 ED3930

GUDID 14897076720092

The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.

TENS PLUS INDUSTRIAL COMPANY

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID14897076720092
NIH Device Record Key6c53cf5a-700d-4d1e-a4b0-096d8d8d5da2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAXUS ES-5
Version Model NumberED3930
Catalog NumberED3930
Company DUNS663211978
Company NameTENS PLUS INDUSTRIAL COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com
Phone1-800-722-8775
Emailinfo@lhasaoms.com

Device Identifiers

Device Issuing AgencyDevice ID
GS114897076720092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWKStimulator, Electro-Acupuncture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-07
Device Publish Date2021-03-30

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