Omron Max Power Relief TENS Therapy Pain Relief PM500

GUDID 10073796635005

Omron TENS Unit with 9 preset modes and 15 intensity levels.

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID10073796635005
NIH Device Record Key675e0af1-1d89-4df6-89c1-ec450e072245
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Max Power Relief TENS Therapy Pain Relief
Version Model NumberPM500
Catalog NumberPM500
Company DUNS054318779
Company NameOmron Healthcare, Inc.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796635008 [Primary]
GS110073796635005 [Package]
Contains: 00073796635008
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NYNStimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-05-06

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