510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN110009Unknown

Restless Leg Device

Mary M. Sorg (an Individual) dba PJ Sleeper'S, Waterford PA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN110009 is the FDA 510(k) clearance record for RESTLESS LEG DEVICE, a class I device, cleared for Mary M. Sorg (An Individual) Dba PJ Sleeper'S on under FDA product code OTX (Foot Wrap For Treating Restless Leg Syndrome Symptoms). FDA's definition for product code OTX reads: "Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system". FDA records list one 510(k) clearance for Mary M. Sorg (An Individual) Dba PJ Sleeper'S. As of , FDA records show no recalls naming DEN110009.

Clearance record

Decision date
Received
(1,056 days to decision)
Product code
OTX Foot Wrap For Treating Restless Leg Syndrome Symptoms
Regulation
21 CFR 890.5760
Device class
Class I
Review panel
Physical Medicine
Applicant
Mary M. Sorg (An Individual) Dba PJ Sleeper'S 2210 Elk Creek Rd., Waterford PA
Third party review
No

Clearances, product code OTX

Trailing 12 months

FDA records hold no clearances under product code OTX in the trailing twelve months.

FDA records show no clearances under product code OTX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OTX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260