COMPUTER SPORTS MEDICINE INC.

Address:101 TOSCA DR.,STOUGHTON,MA,02072,US

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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) (7)

Premarket Exempt

Yes

Clear

HUMAC NORM - 00860139000308 Catalog Number : 502140-00

Device Description : HUMAC NORM Extremity System; Dynamometer

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC NORM (R) - 00860139000315 Catalog Number : 504191

Device Description : HUMAC NORM Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC Cybex NORM (R) - 00860139000322 Catalog Number : 504192

Device Description : HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC Biodex System2 (R) - 00860139000339 Catalog Number : 503677

Device Description : HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC Biodex System3 Rev0 (R) - 00860139000346 Catalog Number : 503678

Device Description : HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC Biodex System3 Rev1 (R) - 00860139000353 Catalog Number : 503679

Device Description : HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

HUMAC Biodex System4 - 00860139000360 Catalog Number : 503680

Device Description : HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished

Device Class : 2

Duns Number: 059291894

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

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