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Found 9 results
510(k) Data Aggregation
K Number
K040679Device Name
RICH-MAR AUTOPRISM INFRARED LAMP
Manufacturer
RICH-MAR CORP.
Date Cleared
2004-05-07
(53 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions
Device Description
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K Number
K031018Device Name
AUTOGEL PAD
Manufacturer
RICH-MAR CORP.
Date Cleared
2003-12-08
(252 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Conductive medium for transmission of therapeutic ultrasound to tissue.
Device Description
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K Number
K032941Device Name
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Manufacturer
RICH-MAR CORP.
Date Cleared
2003-10-22
(30 days)
Product Code
IPF, GZJ, IMG, IMI, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:
- 1. Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy. 2.
- 3. Increasing local blood circulation.
- 4. Muscle re-education.
- 5. Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.
Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:
- 1. Symptomatic relief of chronic intractable pain.
- 2. Management of pain associated with post-traumatic or post operative conditions.
Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
- 1. Relief of pain
- 2. Muscle spasms
- 3. Joint contractures
But NOT for the treatment of malignancies
Device Description
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K Number
K021483Device Name
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
Manufacturer
RICH-MAR CORP.
Date Cleared
2002-09-13
(128 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
- Relief of pain
- Muscle spasms
- Joint contractures
But NOT for the treatment of malignancies
Device Description
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K Number
K013770Device Name
MODIFICATION TO: WINNER ST-2 STIMULATOR
Manufacturer
RICH-MAR CORP.
Date Cleared
2002-01-18
(66 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:
- 1. Relaxation of muscle spasms.
- 2. Prevention or retardation of disuse atrophy.
- 3. Increasing local blood circulation.
- 4. Muscle re-education.
- 5. Maintaining or increasing range of motion.
- 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:
- 1. Symptomatic relief of chronic intractable pain.
- 2. Management of pain associated with post-traumatic or post operative conditions.
Device Description
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K Number
K013771Device Name
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
Manufacturer
RICH-MAR CORP.
Date Cleared
2002-01-18
(66 days)
Product Code
IPF, GZJ, IMG, IMI, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:
1. Relaxation of muscle spasms.
2. Prevention or retardation of disuse atrophy.
3. Increasing local blood circulation.
4. Muscle re-education.
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:
1. Symptomatic relief of chronic intractable pain.
2. Management of pain associated with post-traumatic or post operative conditions.
Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
1. Relief of pain
2. Muscle spasms
3. Joint contractures
But NOT for the treatment of malignancies
Device Description
Not Found
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K Number
K012848Device Name
WINNER CM4 COMBINATION UNIT
Manufacturer
RICH-MAR CORP.
Date Cleared
2001-10-25
(63 days)
Product Code
GZJ, IPF, LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THERAPEUTIC ULTRASOUND
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
1) Relief of pain
2) Muscle Spasms
3) Joint contractures
But NOT for the treatment of malignancies
MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions:
1) Symptomatic relief of chronic, intractable pain.
2) Management of pain associated with post-traumatic or post-operative conditions.
Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:
1) Relaxation of muscle spasms.
2) Prevention or retardation of disuse atrophy.
3) Increasing local blood circulation.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
(Quadpolar Interferential and Microamperage Pulsed Current)
1) Symptomatic relief of chronic, intractable pain,
2) Management of pain associated with post-traumatic or post-operative conditions.
Device Description
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K Number
K000808Device Name
RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
Manufacturer
RICH-MAR CORP.
Date Cleared
2000-08-25
(165 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982544Device Name
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
Manufacturer
RICH-MAR CORP.
Date Cleared
1998-11-19
(121 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
RICH-MAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
- l) Relief of pain
- 2) Muscle Spasms
- 3) Joint contractures
But NOT for the treatment of malignancies
Device Description
Rich-Mar US500, US750, US1000, Therapeutic Ultrasound Devices
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