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
K912289Substantially Equivalent

Ultima Xs, Modification

American Imex, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912289 is the FDA 510(k) clearance record for ULTIMA XS, MODIFICATION, a class II device, cleared for American Imex on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 11 510(k) clearances for American Imex, from to . As of , FDA records show no recalls naming K912289.

Clearance record

Decision date
Received
(183 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
American Imex 16520 Aston St., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code GZJ

Trailing 12 months
2 clearances under product code GZJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260