Search Results
Found 4 results
510(k) Data Aggregation
K Number
K023000Device Name
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES
Manufacturer
HOME CARE TECHNOLOGY CO., LTD.
Date Cleared
2003-10-29
(415 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
HOME CARE TECHNOLOGY 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 at some limited ● positions 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.
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.
Device Description
Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4
Ask a Question
K Number
K022998Device Name
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
Manufacturer
HOME CARE TECHNOLOGY CO., LTD.
Date Cleared
2003-05-20
(253 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
HOME CARE TECHNOLOGY 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.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Device Description
Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312
Ask a Question
K Number
K023001Device Name
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
Manufacturer
HOME CARE TECHNOLOGY CO., LTD.
Date Cleared
2003-04-08
(211 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
HOME CARE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Specific Indications: Used to apply an electrical current to electrodes on patients 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. .
Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Device Description
Not Found
Ask a Question
K Number
K022917Device Name
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
Manufacturer
HOME CARE TECHNOLOGY CO., LTD.
Date Cleared
2003-03-04
(182 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
HOME CARE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Device Description
Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series
Ask a Question
Page 1 of 1