AccessGUDID - DEVICE: EvalTech (10850390007328)

GUDID

Device Identifier (DI) Information

Brand Name: EvalTech
Version or Model: EvalTech
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTE TECHNOLOGIES, INC.

Primary DI Number: 10850390007328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021461470 *Terms of Use

Device Description: A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63457	Biomechanical function analysis system, force-testing, stationary	A stationary computerized device assembly designed for analysis of biomechanical/neuromuscular strength using dedicated hardware (e.g., dynamometers); the system may be designed for additional neuromuscular function testing (e.g., range of motion or pain/touch sensitivity). It includes a non-portable piece of primary hardware that allows for strength testing during a variety of movements (e.g., lifting, pulling), typically with a variety of dynamometer attachments (e.g., handles, bars, cables) and computer interface devices/computer with dedicated software. It is not intended for interactive gaming and is not based on tracking movement through space (i.e., not a kinesiology system).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 55 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 55 and 106 KiloPascal
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ac317f42-8a66-4ac2-a2f6-1ad1cf93b6c5
Public Version Date: May 13, 2020
Public Version Number: 5
DI Record Publish Date: August 25, 2016