510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864870Substantially Equivalent

Thumbshelper Power Ring

Levolon Company, Inc., Forest Park GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864870 is the FDA 510(k) clearance record for THUMBSHELPER POWER RING, a class I device, cleared for Levolon Company, Inc. on under FDA product code LQX (Device, Finger-Sucking). FDA records list one 510(k) clearance for Levolon Company, Inc. As of , FDA records show no recalls naming K864870.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LQX Device, Finger-Sucking
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Levolon Company, Inc. 343 Pineridge Dr., Forest Park GA
Third party review
No

Clearances, product code LQX

Trailing 12 months

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

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