OTX

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Foot Wrap For Treating Restless Leg Syndrome Symptoms

Device class

Class I (low risk)

Regulation

21 CFR 890.5760

Medical specialty

Physical Medicine

FDA definition

Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.

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