SensaTONE for MEN

GUDID 05060079211283

The SensaTONE for MEN is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

BODY CLOCK HEALTH CARE LIMITED

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID05060079211283
NIH Device Record Keyfba42a22-e71a-42e3-be75-d2e6dcb8eab3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSensaTONE for MEN
Version Model NumberPF-SENSATONEMEN
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
GS105060079211283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2017-02-12

Devices Manufactured by BODY CLOCK HEALTH CARE LIMITED

B364792117400 - USA 40x100 Body Clock Branded Electrodes2019-10-23 Indications for Use: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patie
05060079210101 - Profile TENS2019-10-23 The Profile TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment
05060079210217 - Flexi TENS2019-10-23 The Flexi TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment i
05060079210224 - Smart TENS2019-10-23 The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment i
05060079210262 - STIMPLUS PRO2019-10-23 The Body Clock Stimplus Pro is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctiv
05060079210675 - SensaTONE2019-10-23 The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in
05060079211283 - SensaTONE for MEN2019-10-23The SensaTONE for MEN is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
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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