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FDA PRODUCT CODE · CLASS I

OTX — Foot Wrap For Treating Restless Leg Syndrome Symptoms

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

DEVICE CLASS
Class I
REGULATION
21 CFR 890.5760
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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