PATHRIGHT MEDICAL INC.

Address:14252 23rd Avenue North,Plymouth,MN,55447,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

Orthosis, Limb Brace (IQI) (1)

Premarket Exempt

Yes

Clear

RestoreX - 00860001453805 Catalog Number : 117

Device Description : RestoreX Kit - penile traction therapy device for the treatment of Peyronie's di RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use

Device Class : 1

Duns Number: 092965880

Premarket Exempt : Yes

Product Code : IQI

Prescription Use : No

Device Count : 1

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