510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202523Substantially Equivalent

TMJ Relax

Moonwalker Innovations, Inc., Medford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202523 is the FDA 510(k) clearance record for TMJ Relax, cleared for Moonwalker Innovations, Inc. on under FDA product code OCO (Mouthguard, Migraine/Tension Headache). FDA's definition for product code OCO reads: "A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular...". FDA records list one 510(k) clearance for Moonwalker Innovations, Inc. As of , FDA records show no recalls naming K202523.

Clearance record

Decision date
Received
(296 days to decision)
Product code
OCO Mouthguard, Migraine/Tension Headache
Device class
Unclassified
Review panel
Unknown
Applicant
Moonwalker Innovations, Inc. 20 Roosevelt Rd., Medford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCO

Trailing 12 months

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

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