BTE TECHNOLOGIES, INC.

BTE TECHNOLOGIES, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Isokinetic Testing And Evaluation (IKK) (6) Exerciser, Measuring (ISD) (2) Exerciser, Powered (BXB) (2)

Premarket Exempt

No Yes

Clear

Simulator II - 10850390007137 Catalog Number :

Device Description : A rehabilitation device for upper extremity strength testing and exercise. The d

Device Class : 1

Duns Number: 021461470

Premarket Exempt : No

Product Code : BXB

Prescription Use : No

Device Count : 1

Simulator II - 10850390007151 Catalog Number :

Device Description : A rehabilitation device for upper extremity strength testing and exercise. The d

Device Class : 1

Duns Number: 021461470

Premarket Exempt : No

Product Code : BXB

Prescription Use : No

Device Count : 1

Primus - 10850390007236 Catalog Number :

Device Description : A very versatile rehabilitation device for upper extremity and lower extremity s

Device Class : 2

Duns Number: 021461470

Premarket Exempt : No

Product Code : ISD

Prescription Use : No

Device Count : 1

PrimusRS - 10850390007243 Catalog Number :

Device Description : A very versatile rehabilitation device for upper extremity and lower extremity s

Device Class : 2

Duns Number: 021461470

Premarket Exempt : No

Product Code : ISD

Prescription Use : No

Device Count : 1

ER - 10850390007311 Catalog Number :

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

EvalTech - 10850390007328 Catalog Number :

Device Description : A rehabilitation system used to quantify muscle strength and range of motion, as

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

Evaluator - 10850390007335 Catalog Number :

Device Description : A portable measurement system for quantifying musculoskeletal strength and range

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

Evaluator EV2 - 10850390007342 Catalog Number :

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

Provider Test Kit (PTK) - 10850390007359 Catalog Number :

Device Description : A rehabilitation system used to quantify muscle strength and range of motion, as

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

EVJ - 10850390007366 Catalog Number :

Device Description : A portable measurement system for quantifying musculoskeletal strength and range

Device Class : 2

Duns Number: 021461470

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

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