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
K915369Substantially Equivalent

The Equalizer

Advanced Rehabilitative Technology, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915369 is the FDA 510(k) clearance record for THE EQUALIZER, a class I device, cleared for Advanced Rehabilitative Technology, Inc. on under FDA product code IKE (Transducer, Miniature Pressure). FDA records list 3 510(k) clearances for Advanced Rehabilitative Technology, Inc., from to . As of , FDA records show no recalls naming K915369.

Clearance record

Decision date
Received
(481 days to decision)
Product code
IKE Transducer, Miniature Pressure
Regulation
21 CFR 890.1615
Device class
Class I
Review panel
Physical Medicine
Applicant
Advanced Rehabilitative Technology, Inc. P.O. Box 34842, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code IKE

Trailing 12 months

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

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