Omron Pocket Pain Pro PM400

GUDID 10073796634008

TENS Therapy Pain Relief device that relieves Chronic, Acute and Arthritic Pain - 5 Preset modes, 10 Intensity levels

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID10073796634008
NIH Device Record Keyeeef88e3-4959-40a6-942f-2be43dd71a93
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Pocket Pain Pro
Version Model NumberPM400
Catalog NumberPM400
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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796634001 [Primary]
GS110073796634008 [Package]
Contains: 00073796634001
Package: Case [12 Units]
In Commercial Distribution
GS150073796634006 [Package]
Contains: 00073796634001
Package: Inner Carton [4 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 Number3
Public Version Date2019-10-23
Device Publish Date2019-03-31

On-Brand Devices [Omron Pocket Pain Pro]

00073796630294Electrotherapy Pocket Pain Pro TENS Unit
10073796634008TENS Therapy Pain Relief device that relieves Chronic, Acute and Arthritic Pain - 5 Preset modes

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