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Found 16 results
510(k) Data Aggregation
K Number
K132137Device Name
MULTISTIM
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2013-09-12
(63 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- I. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, TNS and Microcurrent waveforms);
- 2. Relaxation of muscle spasm (all waveforms except Microcurrent);
- 3. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent);
- 4. Increasing local blood flow (all waveforms except Microcurrent);
- 5. Muscle re-education (all waveforms except Microcurrent);
- 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent); and
- 7. Maintaining or increasing range of motion (all waveforms except Microcurrent).
Device Description
Not Found
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K Number
K124010Device Name
ACCUSONIC ADVANTAGE
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2013-08-23
(239 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.
Device Description
Not Found
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K Number
K120171Device Name
ACCUSONIC ADVANTAGE
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2012-05-04
(105 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are:
1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.
Device Description
Not Found
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K Number
K030880Device Name
VECTORSONIC, MODEL VU-270
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2003-04-18
(29 days)
Product Code
IMG
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use for the interferential therapy are:
- Relaxation of muscle spasm: 1.
- 2. Prevention or retardation of disuse atrophy:
- 3. Increasing local blood flow;
- 4. Muscle re-education;
- Immediate post-surgical stimulation of calf muscles to prevent 5. venous thrombosis; and
- Maintaining or increasing range of motion. 6.
The indications for use for the ultrasound therapy are:
- 1. Relief or reduction of pain;
- 2. Reduction of muscle spasm;
- 3. Joint contracture; and
- 4. Local increase in circulation.
The indication for use for the combined therapy is:
- Reduction of muscle spasm. 1.
Device Description
Not Found
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K Number
K030648Device Name
VECTORSURGE 5 MODEL 470
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2003-03-28
(28 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are:
1. Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
2. Relaxation of muscle spasm (Interferential Mode);
3. Prevention or retardation of disuse atrophy (Interferential Mode);
4. Increasing local blood flow (Interferential Mode);
5. Muscle re-education (Interferential Mode);
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (Interferential Mode); and
7. Maintaining or increasing range of motion (Interferential Mode).
Device Description
Not Found
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K Number
K030410Device Name
ACCOUSONIC PLUS, MODEL AP-170
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2003-02-20
(13 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are:
- Relief or reduction of pain;
- Reduction of muscle spasm;
- Joint contracture; and
- Local increase in circulation.
Device Description
Not Found
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K Number
K020119Device Name
VECTORSONIC, MODEL VU-200
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2002-07-22
(189 days)
Product Code
IMG
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use for the interferential therapy are:
1. Relaxation of muscle spasm;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood flow;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.
The indications for use for the ultrasound therapy are:
1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.
The indication for use for the combined therapy is:
1. Reduction of muscle spasm.
Device Description
Not Found
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K Number
K011955Device Name
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2001-07-16
(24 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are:
- Relief or reduction of pain; 1.
- Reduction of muscle spasm; 2.
- Joint contracture; and 3.
- 4. Local increase in circulation.
Device Description
Modification to: Accusonic Plus, Model AP-100
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K Number
K001897Device Name
MULTI-STIM, MODEL MS-100
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2001-06-12
(356 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002058Device Name
VECTORSURGE 5, MODEL VS-500
Manufacturer
METRON MEDICAL AUSTRALIA PTY LTD
Date Cleared
2001-05-29
(327 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
METRON MEDICAL AUSTRALIA PTY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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