510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN110011Unknown

Symphony Device

Sensory Medical Inc, San Clemente CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN110011 is the FDA 510(k) clearance record for SYMPHONY DEVICE, a class II device, cleared for Sensory Medical, Inc. on under FDA product code OVP (Vibratory Counter-Stimulation). FDA's definition for product code OVP reads: "A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome". FDA records list one 510(k) clearance for Sensory Medical, Inc. As of , FDA records show no recalls naming DEN110011.

Clearance record

Decision date
Received
(889 days to decision)
Product code
OVP Vibratory Counter-Stimulation
Regulation
21 CFR 882.5895
Device class
Class II
Review panel
Physical Medicine
Applicant
Sensory Medical, Inc. 1235 Puerta Del Sol #500, San Clemente CA
Third party review
No

Clearances, product code OVP

Trailing 12 months

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

FDA records show no clearances under product code OVP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OVP, 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