510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K992372Substantially Equivalent

The Leadaway

Therapy Equipment, Inc., West Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992372 is the FDA 510(k) clearance record for THE LEADAWAY, a class II device, cleared for Therapy Equipment, Inc. on under FDA product code IKD (Cable, Electrode). FDA records list one 510(k) clearance for Therapy Equipment, Inc. As of , FDA records show no recalls naming K992372.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IKD Cable, Electrode
Regulation
21 CFR 890.1175
Device class
Class II
Review panel
Physical Medicine
Applicant
Therapy Equipment, Inc. 13860 Wellington Trace, #310, West Palm Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code IKD

Trailing 12 months

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

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