PROFILE EMS

GUDID 05060079210347

The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by pas

BODY CLOCK HEALTH CARE LIMITED

Physical therapy ultrasound/neuromuscular stimulation system
Primary Device ID05060079210347
NIH Device Record Keyeb2ba8e6-657d-449e-9eec-2e04fd559b7f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFILE EMS
Version Model NumberEM-PROFILE_EMS
Company DUNS504712829
Company NameBODY CLOCK HEALTH CARE 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060079210347 [Primary]

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-02-12

Devices Manufactured by BODY CLOCK HEALTH CARE LIMITED

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05060079211283 - SensaTONE for MEN2019-10-23 The SensaTONE for MEN is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive trea
05060079211733 - Obi TENS2019-10-23 The Obi TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in

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