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

Transport, Patient, Powered

21 CFR 890.5150 / Physical Medicine
FDA source (opens on fda.gov)

ILK is the FDA product code for Transport, Patient, Powered, a class II device type, regulated under 21 CFR 890.5150. FDA's definition for this code 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., attendant-operated portable stair-climbing chairs). This generic type of device...". As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
ILK
Device name
Transport, Patient, Powered
FDA definition
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., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
Regulation
21 CFR 890.5150
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
36
Ingested recalls
7

Clearances, product code ILK

By decision year
36 clearances under product code ILK with a decision year between 1977 and 2024, 2003 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code ILK by decision year
YearClearances
19771
19801
19851
19863
19872
19883
19891
19901
19921
19932
19971
20021
20037
20081
20091
20102
20111
20123
20141
20231
20241

Applicants with the most clearances

Product code ILK
Applicants holding the most 510(k) clearances under product code ILK
ApplicantClearances
Bruno Independent Living Aids, Inc.7
Services Industriels Savaria, Inc.3
AAT Alber Antriebstechnik GmbH2
T.B.S., Inc.2
Thyssenkrupp Accessibility B.V.2
Climbing Steps Inc1
Devine Medical Products1
Electric Mobility1
Hoveround Corp.1
Independent Transfer Equipment Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code