DEVICE: Seat Ergometer ergoselect 100 P (04059358000275)
Device Identifier (DI) Information
Seat Ergometer ergoselect 100 P
1611010
In Commercial Distribution
ergoline GmbH
1611010
In Commercial Distribution
ergoline GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
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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 Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 61 Kilogram |
Height: 135 Centimeter |
Width: 46 Centimeter |
Length: 90 Centimeter |
Device Record Status
d5cd24b9-8ab5-48eb-8529-82de956ae8d3
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