IWALK FREE

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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

Crutch (IPR) (1) Orthosis, Limb Brace (IQI) (1)

Premarket Exempt

Yes

Clear

iWALK3.0, the iWALKFree 3.0 Hands Free Crutch - 00860002590813 Catalog Number :

Device Description : iWALK3.0 is a assistive mobility device most accurately described as a hands fre iWALK3.0 is a assistive mobility device most accurately described as a hands free crutch. It acts as a temporary lower leg orthotic or prosthetic and provides hands free mobility for non-weight bearing lower leg injuries. It recruits the uninjured upper leg of the user to provide ambulation.

Device Class : 1

Duns Number: 079461204

Premarket Exempt : Yes

Product Code : IQI, IPR

Prescription Use : No

Device Count : 1

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