Revitive Advanced 2615

GUDID 10858058005099

Neuromuscular Electrical Stimulation Device

ACTEGY LIMITED

Physical therapy transcutaneous electrical stimulation system, line-powered
Primary Device ID10858058005099
NIH Device Record Key6fd71211-df52-4b85-a86a-752bbb70d5bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevitive Advanced
Version Model NumberRMV
Catalog Number2615
Company DUNS735575941
Company NameACTEGY LIMITED
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8772603114
Emailus.info@actegy.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100858058005092 [Primary]
GS110858058005099 [Package]
Contains: 00858058005092
Package: Outer carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-23
Device Publish Date2018-04-23

Devices Manufactured by ACTEGY LIMITED

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