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510(k) Data Aggregation
K Number
K040512Device Name
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2004-05-27
(90 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The model WL-2402, WL-2403 TENS are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
- The model WL-2401 TENS is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
Device Description
Not Found
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K Number
K033857Device Name
T-TECH DIGITAL, MODEL WL-22XXA SERIES
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2003-12-19
(8 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications For Use (Available for WL-2202A, WL-2203A & 'TENS function' of WL-2205A):
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Indications For Use (Available for WL-2204A, WL-2204A-P1, WL-2204A-P2 & 'EMS function' of WL-2205A):
- · 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.
- Maintaining or increasing range of motion.
Device Description
The T-tech Digital TENS series, including WL-2202A. WL-2204A. WL-2204A. WL-2204A-P1. WL-2204A-P2, and WL-2205A are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
T-tech Digital TENS series, models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for T-tech Digital TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
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K Number
K030537Device Name
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2003-03-20
(28 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B): - 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. - Maintaining or increasing range of motion.
Device Description
The Digi-Pro TENS series, including WL-2203B, WL-2204B-P1, WL-2204B-P1, WL-2204B-P2, and WL-2205B are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B, consist mainly of two parts: the stimulus generator, electrode. The stimulus qenerator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
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K Number
K020020Device Name
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2002-12-30
(361 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.
Device Description
The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.
The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification.
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K Number
K020314Device Name
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2002-04-30
(90 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications For Use (Available for WL-2203 & 'TENS function' of WL-2205): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204 & 'EMS function' of WL-2205): - 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. - Maintaining or increasing range of motion.
Device Description
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
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K Number
K021359Device Name
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
Manufacturer
WELL-LIFE HEALTHCARE, INC.
Date Cleared
2002-04-30
(90 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
WELL-LIFE HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
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.
Maintaining or increasing range of motion.
Device Description
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous r he Dig TTO reason of sed for pain relief and/or powered muscle stimulator by applying an electrical norrent to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: Digit to TENO benerator, electrode. The stimulus generator generates the output current specified the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
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