DEVICE: HUMAC NORM (R) (00860139000315)
Device Identifier (DI) Information
HUMAC NORM (R)
504191
In Commercial Distribution
504191
COMPUTER SPORTS MEDICINE INC.
504191
In Commercial Distribution
504191
COMPUTER SPORTS MEDICINE INC.
HUMAC NORM Extremity System; Dynamometer – Refurbished
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
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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34395 | Back/leg/chest dynamometer |
An analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess a variety of movements (e.g., leg abduction, lifting) and is typically used to test and control a patient's muscle strength as part of a rehabilitation program.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IKK | System, Isokinetic Testing And Evaluation |
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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Special Storage Condition, Specify: Relative Humidity for Storage and Handling is noncondensing |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
558ea91e-e215-4a30-ac07-88998c69df1b
March 29, 2018
2
September 14, 2016
March 29, 2018
2
September 14, 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
[?]
781-297-2034
dev@csmisolutions.com
dev@csmisolutions.com