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510(k) Data Aggregation
K Number
K071624Device Name
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
Manufacturer
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2007-11-27
(166 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.
Device Description
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
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K Number
K071320Device Name
EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
Manufacturer
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2007-08-17
(99 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy ●
- . Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- . Maintaining or increasing range of motion
Device Description
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin.
Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
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K Number
K070890Device Name
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
Manufacturer
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
Date Cleared
2007-06-29
(91 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EVERLIFE MEDICAL EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic acute pain.
Device Description
The IF-100507 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the IF-100507 can provide results from this electrical stimulation.
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