FDA.reportPublic FDA data

Simulator II

Primary DI
10850390007151
Brand
Simulator II
Company
BTE TECHNOLOGIES, INC.
Model
Sim II 5
Device description
A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic 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
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800007000WORK SIMULATORBaltimore Therapeutic Equipment Co.1980-01-21BXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850390007151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085039000715110850390007151

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).

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
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10850390007373EvaluatorEvaluator EV2020-05-18
10850390007236PrimusPrimus+2016-08-25
10850390007366EVJEvaluator EVJ2020-05-12
10850390007427MCU Multi-Cervical UnitMCU 22016-08-25
10850390007816EccentronLE12016-08-25
10850390007243PrimusRSPrimusRS2016-08-25
10850390007328EvalTechEvalTech2016-08-25
10850390007335EvaluatorEvaluator2016-08-25
10850390007359Provider Test Kit (PTK)12016-08-25
10850390007137Simulator IISim II 032016-08-25
10850390007342Evaluator EV2EV22016-08-25
10850390007311ERER2016-08-25

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