BODY CLOCK HEALTH CARE LIMITED

Address:108 GEORGE LANE,LONDON, ENGLAND London, City of,GB

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (7) Electrode, Cutaneous (GXY) (1) Stimulator, Muscle, Powered (IPF) (1)

Premarket Exempt

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Profile TENS - 05060079210101 Catalog Number :

Device Description : The Profile TENS is used for the symptomatic relief and management of chronic in The Profile TENS 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 acute pain.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Flexi TENS - 05060079210217 Catalog Number :

Device Description : The Flexi TENS is used for the symptomatic relief and management of chronic intr The Flexi TENS 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.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Smart TENS - 05060079210224 Catalog Number :

Device Description : The SMART TENS is used for the symptomatic relief and management of chronic intr The SMART TENS 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 acute pain.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

STIMPLUS PRO - 05060079210262 Catalog Number :

Device Description : The Body Clock Stimplus Pro is used for the symptomatic relief and management of The Body Clock Stimplus Pro 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 acute pain.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

PROFILE EMS - 05060079210347 Catalog Number :

Device Description : The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator in The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:- Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm;- Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation;- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

SensaTONE - 05060079210675 Catalog Number :

Device Description : The SensaTONE is used for the symptomatic relief and management of chronic intra The SensaTONE 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.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

SensaTONE for MEN - 05060079211283 Catalog Number :

Device Description : The SensaTONE for MEN is used for the symptomatic relief and management of chron 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.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

Obi TENS - 05060079211733 Catalog Number :

Device Description : The Obi TENS is used for the symptomatic relief and management of chronic intrac The Obi TENS 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.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

USA 40x100 Body Clock Branded Electrodes - B364792117400 Catalog Number :

Device Description : Indications for Use:Adhesive electrodes are intended for use as the disposable, Indications for Use:Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Device Class : 2

Duns Number: 504712829

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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