510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952043Substantially Equivalent

Back Massager

Eight Corners, Inc., East Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952043 is the FDA 510(k) clearance record for BACK MASSAGER, a class I device, cleared for Eight Corners, Inc. on under FDA product code LYG (Massager, Therapeutic, Manual). FDA records list one 510(k) clearance for Eight Corners, Inc. As of , FDA records show no recalls naming K952043.

Clearance record

Decision date
Received
(123 days to decision)
Product code
LYG Massager, Therapeutic, Manual
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Applicant
Eight Corners, Inc. 10 B, Auer Ct., East Brunswick NJ
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