Rom Technologies, Inc

Address:101 Silvermine Rd,Brookfield,CT,06804,US

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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

Goniometer, Ac-Powered (KQX) (1) System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

Yes

Clear

AccuAngle - 00860002828701 Catalog Number : 28000

Device Description : Battery powered device intended to evaluate joint function by measuring and reco Battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint

Device Class : 1

Duns Number: 117410715

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : Yes

Device Count : 1

PortableConnect - 00860002828718 Catalog Number : 10100

Device Description : The PortableConnect System is a rehabilitative exercise therapy device to increa The PortableConnect System is a rehabilitative exercise therapy device to increase range of motion

Device Class : 2

Duns Number: 117410715

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

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