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Found 7 results
510(k) Data Aggregation
K Number
K091045Device Name
SMART TENS, MODEL: D-BC05T
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2009-12-18
(249 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 Description
Not Found
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K Number
K041359Device Name
BODY CLOCK STIMPLUS AND STIMPLUS PRO
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2004-08-20
(91 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and post-traumatic acute pain.
Device Description
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
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K Number
K022849Device Name
BODY CLOCK TENS N' TONE
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2003-05-20
(266 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a TENS unit, the Body Clock Duo 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.
As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Relaxation of muscle spasms; ●
- Prevention or retardation of disuse atrophy; ●
- Increasing local blood circulation; ●
- Muscle re-education; ●
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
- Maintaining or increasing range of motion. ●
Device Description
The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
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K Number
K021846Device Name
804SIII; 804W; LIBRA TENS; 410; S-TENS II
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2002-11-22
(170 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 804SIII, 804W, Libra TENS, 410 and S-TENSII are 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 Description
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.
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K Number
K022731Device Name
V TENS PLUS
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2002-11-14
(90 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V TENS Plus 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 Description
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
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K Number
K022493Device Name
EMS 400
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2002-10-11
(74 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Body Clock EMS 400 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Relaxation of muscle spasms;
- Prevention or retardation of disuse atrophy;
- Increasing local blood circulation;
- Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- Maintaining or increasing range of motion.
Device Description
The EMS 400 a dual channel EMS (Powered Muscle Stimulator) unit. It is identical to the Altoona EMS 400 (K913272). It has two intensity (amplitude) dials for each channel, placed on the front of the unit. Directly below the left-hand-side intensity dial is a pulse rate dial, which sets the pulse rate for both channels. Below the right-hand dial is a timer dial, which controls the time of each cycle when cycle or reciprocal mode is used. If the dial is set to 0, the unit provides a constant mode.
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K Number
K022076Device Name
FIRST CHOICE & FIRST CHOICE PLUS
Manufacturer
BODY CLOCK HEALTH CARE LTD
Date Cleared
2002-09-24
(90 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
BODY CLOCK HEALTH CARE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The First Choice and First Choice Plus are 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 Description
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.
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