510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912512Substantially Equivalent

Taichi Stick Massager

Focus International, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912512 is the FDA 510(k) clearance record for TAICHI STICK MASSAGER, a class I device, cleared for Focus International, Inc. on under FDA product code LYG (Massager, Therapeutic, Manual). FDA records list one 510(k) clearance for Focus International, Inc. As of , FDA records show no recalls naming K912512.

Clearance record

Decision date
Received
(92 days to decision)
Product code
LYG Massager, Therapeutic, Manual
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Focus International, Inc. 416 Hungerford Dr., Suite 204, Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code LYG

Trailing 12 months

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

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