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
K103122Substantially Equivalent

C-Max, C-Max U1, C-Max U1 160Kg, C-Max U2, C-Max U2 160Kg, S-Max, S-Max Aviation, S-Max Sella, S-Max Sella 160Kg

AAT Alber Antriebstechnik GmbH, Texas City TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103122 is the FDA 510(k) clearance record for C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG, a class II device, cleared for Aat Alber Antriebstechnik GmbH on under FDA product code ILK (Transport, Patient, Powered). FDA's definition for product code ILK reads: "A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g...". FDA records list 3 510(k) clearances for Aat Alber Antriebstechnik GmbH, from to . As of , FDA records show no recalls naming K103122.

Clearance record

Decision date
Received
(70 days to decision)
Product code
ILK Transport, Patient, Powered
Regulation
21 CFR 890.5150
Device class
Class II
Review panel
Physical Medicine
Applicant
Aat Alber Antriebstechnik GmbH 2611 Shark Cir., Texas City TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILK

Trailing 12 months

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

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