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

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

Device Class : 2

Duns Number: 117410715

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

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