DEVICE: Recumbent Ergometer ergoselect 600 K HF (04059358000367)
Device Identifier (DI) Information
Recumbent Ergometer ergoselect 600 K HF
1615530
In Commercial Distribution
ergoline GmbH
1615530
In Commercial Distribution
ergoline GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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10383 | Bicycle ergometer |
A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training, or rehabiltation and measures this related muscle activity at defined workloads.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ISD | Exerciser, Measuring |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 86 Kilogram |
Height: 108 Centimeter |
Width: 75 Centimeter |
Length: 165 Centimeter |
Device Record Status
9522c0be-1e2e-493b-b6eb-472328595052
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined