Primary Device ID | 10850390007380 |
NIH Device Record Key | 1c13d994-6ed1-4014-8b06-1fa79985283e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Prism |
Version Model Number | Prism1 |
Company DUNS | 021461470 |
Company Name | BTE TECHNOLOGIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com | |
Phone | 410-850-0333 |
Customer_Service@btetechnologies.com |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10850390007380 [Primary] |
IKK | System, Isokinetic Testing And Evaluation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-27 |
Device Publish Date | 2022-06-17 |
10850390007380 - Prism | 2022-06-27A 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 - Prism | 2022-06-27 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne |
10850390007373 - Evaluator | 2020-05-26 A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available th |
10850390007427 - MCU Multi-Cervical Unit | 2020-05-13 A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. |
10850390007816 - Eccentron | 2020-05-13 A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measu |
10850390007236 - Primus | 2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of |
10850390007243 - PrimusRS | 2020-05-13 A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer of |
10850390007328 - EvalTech | 2020-05-13 A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities ne |
10850390007335 - Evaluator | 2020-05-13 A portable measurement system for quantifying musculoskeletal strength and range of motion. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRISM 98890725 not registered Live/Pending |
CASETEAM LLC 2024-12-07 |
PRISM 98879586 not registered Live/Pending |
Pediatric Research In Sports Medicine Society Inc 2024-12-01 |
PRISM 98875939 not registered Live/Pending |
Nightingale Dental Business Services, LLC 2024-11-27 |
PRISM 98867761 not registered Live/Pending |
Rosen's, Inc. 2024-11-22 |
PRISM 98853581 not registered Live/Pending |
LIGHTRIVER SOFTWARE, INC. 2024-11-14 |
PRISM 98825940 not registered Live/Pending |
Metron Sustainable Services, Inc. 2024-10-29 |
PRISM 98735612 not registered Live/Pending |
Treasure Data, Inc. 2024-09-05 |
PRISM 98624647 not registered Live/Pending |
Logical AI Governance 2024-06-28 |
PRISM 98593780 not registered Live/Pending |
PRISM Political Risk Management Limited 2024-06-10 |
PRISM 98575731 not registered Live/Pending |
Pirate Trading LLC 2024-05-30 |
PRISM 98496963 not registered Live/Pending |
Ridgeline International, LLC 2024-04-12 |
PRISM 98210856 not registered Live/Pending |
PREMIER PHYSICAL THERAPY AND WELLNESS P.C. 2023-10-05 |