510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OTXClass I

Foot Wrap For Treating Restless Leg Syndrome Symptoms

21 CFR 890.5760 / Physical Medicine
FDA source (opens on fda.gov)

OTX is the FDA product code for Foot Wrap For Treating Restless Leg Syndrome Symptoms, a class I device type, regulated under 21 CFR 890.5760. FDA's definition for this code reads: "Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OTX
Device name
Foot Wrap For Treating Restless Leg Syndrome Symptoms
FDA definition
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Regulation
21 CFR 890.5760
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OTX

By decision year
1 clearance under product code OTX with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OTX by decision year
YearClearances
20131

Applicants with the most clearances

Product code OTX
Applicants holding the most 510(k) clearances under product code OTX
ApplicantClearances
Mary M. Sorg (an Individual) dba PJ Sleeper'S1

Companies listing this code with FDA

Companies whose registered establishments list this code