FDA.reportPublic FDA data

PrimusRS

Primary DI
10850390007243
Brand
PrimusRS
Company
BTE TECHNOLOGIES, INC.
Model
PrimusRS
Device description
A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933611000THE BTE WS30Baltimore Therapeutic Equipment Co.1994-06-20ISD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850390007243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085039000724310850390007243

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis system, force-testing, stationaryA 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure55 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure55 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
410-850-0333Customer_Service@btetechnologies.com

Regulatory Flags#

DUNS number
021461470
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850390007380PrismPrism12022-06-17
10850390007373EvaluatorEvaluator EV2020-05-18
10850390007236PrimusPrimus+2016-08-25
10850390007366EVJEvaluator EVJ2020-05-12
10850390007427MCU Multi-Cervical UnitMCU 22016-08-25
10850390007816EccentronLE12016-08-25
10850390007328EvalTechEvalTech2016-08-25
10850390007335EvaluatorEvaluator2016-08-25
10850390007359Provider Test Kit (PTK)12016-08-25
10850390007137Simulator IISim II 032016-08-25
10850390007151Simulator IISim II 52016-08-25
10850390007342Evaluator EV2EV22016-08-25
10850390007311ERER2016-08-25

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