AccessGUDID - DEVICE: Evaluator (10850390007373)

GUDID

Device Identifier (DI) Information

Brand Name: Evaluator
Version or Model: Evaluator EV
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BTE TECHNOLOGIES, INC.

Primary DI Number: 10850390007373
Issuing Agency: GS1
Commercial Distribution End Date: June 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 021461470 *Terms of Use

Device Description: A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model.

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?
63456	Biomechanical function analysis system, force-testing, portable	A portable computerized device assembly with multiple force-sensing hardware designed for analysis of biomechanical/neuromuscular function by enabling performance of: 1) multiple functional strength tests using a variety of hardware (e.g., dynamometers, pinchmeters); or 2) strength testing with additional neuromuscular function testing (range of motion or pain/touch sensitivity) using additional hardware (e.g., goniometer, algometer). The system is typically designed so results can be displayed on an off-the-shelf computer/smartphone. It is not intended for interactive gaming and is not primarily based on analysing movement through motion sensing (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: 466d3c6a-2d9b-4412-b50d-b59416d49ce4
Public Version Date: June 17, 2022
Public Version Number: 2
DI Record Publish Date: May 18, 2020