Prism

GUDID 10850390007380

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
Primary Device ID10850390007380
NIH Device Record Key1c13d994-6ed1-4014-8b06-1fa79985283e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrism
Version Model NumberPrism1
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
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com
Phone410-850-0333
EmailCustomer_Service@btetechnologies.com

Operating and Storage Conditions

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
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
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
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
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
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
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
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
GS110850390007380 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-27
Device Publish Date2022-06-17

Devices Manufactured by BTE TECHNOLOGIES, INC.

10850390007380 - Prism2022-06-27A 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.
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 - EvalTech2020-05-13 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.

Trademark Results [Prism]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRISM
PRISM
98890725 not registered Live/Pending
CASETEAM LLC
2024-12-07
PRISM
PRISM
98879586 not registered Live/Pending
Pediatric Research In Sports Medicine Society Inc
2024-12-01
PRISM
PRISM
98875939 not registered Live/Pending
Nightingale Dental Business Services, LLC
2024-11-27
PRISM
PRISM
98867761 not registered Live/Pending
Rosen's, Inc.
2024-11-22
PRISM
PRISM
98853581 not registered Live/Pending
LIGHTRIVER SOFTWARE, INC.
2024-11-14
PRISM
PRISM
98825940 not registered Live/Pending
Metron Sustainable Services, Inc.
2024-10-29
PRISM
PRISM
98735612 not registered Live/Pending
Treasure Data, Inc.
2024-09-05
PRISM
PRISM
98624647 not registered Live/Pending
Logical AI Governance
2024-06-28
PRISM
PRISM
98593780 not registered Live/Pending
PRISM Political Risk Management Limited
2024-06-10
PRISM
PRISM
98575731 not registered Live/Pending
Pirate Trading LLC
2024-05-30
PRISM
PRISM
98496963 not registered Live/Pending
Ridgeline International, LLC
2024-04-12
PRISM
PRISM
98210856 not registered Live/Pending
PREMIER PHYSICAL THERAPY AND WELLNESS P.C.
2023-10-05

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