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Found 4 results
510(k) Data Aggregation
K Number
K003433Device Name
NEURO-TRAIN III (3)
Manufacturer
Date Cleared
2001-06-15
(221 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
STERNE EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K980158Device Name
MYO-TRAIN V (5)
Manufacturer
Date Cleared
1998-07-28
(193 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
STERNE EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Myo-train V may be used for the following indications:
- 1) Relaxation of muscle spasm.
- Prevention or retardation of disuse atrophy. 2)
- Increasing local blood circulation. 3)
- 4) Muscle re-education.
- Maintaining or increasing range of motion. 5)
Device Description
Not Found
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K Number
K972204Device Name
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
Manufacturer
Date Cleared
1997-10-08
(118 days)
Product Code
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
STERNE EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES
Device Description
STERNE ACU-RAY HF
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K Number
K970155Device Name
NEURO-TRAIN II (2)
Manufacturer
Date Cleared
1997-03-17
(60 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
STERNE EQUIPMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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