Omron TENS Total Power + Heat for Canada PM800CAN

GUDID 10073796800311

Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to relieve muscle and joint pain.

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID10073796800311
NIH Device Record Key9147df99-7c44-47b6-8ae6-0db0ba873b06
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron TENS Total Power + Heat for Canada
Version Model NumberPM800CAN
Catalog NumberPM800CAN
Company DUNS054318779
Company NameOmron Healthcare, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Phone800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796800314 [Primary]
GS110073796800311 [Package]
Contains: 00073796800314
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

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