EvalTech

GUDID 10850390007328

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.

BTE TECHNOLOGIES, INC.

Biomechanical function analysis system, force-testing, stationary Biomechanical function analysis system, force-testing, stationary
Primary Device ID10850390007328
NIH Device Record Keyac317f42-8a66-4ac2-a2f6-1ad1cf93b6c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvalTech
Version Model NumberEvalTech
Company DUNS021461470
Company NameBTE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110850390007328 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-13
Device Publish Date2016-08-25

Devices Manufactured by BTE TECHNOLOGIES, INC.

10850390007380 - Prism2022-06-27 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne
10850390007373 - Evaluator2020-05-26 A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available th
10850390007427 - MCU Multi-Cervical Unit2020-05-13 A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength.
10850390007816 - Eccentron2020-05-13 A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measu
10850390007236 - Primus2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of
10850390007243 - PrimusRS2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of
10850390007328 - EvalTech2020-05-13A 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.
10850390007328 - EvalTech2020-05-13 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne
10850390007335 - Evaluator2020-05-13 A portable measurement system for quantifying musculoskeletal strength and range of motion.

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