FDA.reportPublic FDA data

s-max

Primary DI
04054959000280
Brand
s-max
Company
AAT Alber Antriebstechnik GmbH
Model
D1611
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILKTransport, Patient, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILKTransport, Patient, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130864000C-MAX+ (PLUS)Aat Alber Antriebstechnik GmbH2014-02-06ILK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054959000280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054959000280040549590002804054959000280

GMDN Terms#

Term, Definition table
TermDefinition
StairclimberA non-fixed mechanical device designed to transport a disabled or infirm person up or down stairs and can be controlled by an attendant/nursing staff, or the user.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314612359
Device count
1
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666601XpeditionTM Powered Stair ChairSTRYKER CORPORATIONILK2025-03-21
10688503700008SavariaSavaria Concord Lifts IncILK2023-07-12
07613327581607XpeditionTM Powered Stair Chair (mid configuration)STRYKER CORPORATIONILK2023-04-26
07613327581614XpeditionTM Powered Stair Chair (mid configuration)STRYKER CORPORATIONILK2023-04-26
07613327581621XpeditionTM Powered Stair Chair (mid configuration)STRYKER CORPORATIONILK2023-04-26
00817650025518PinnacleHarmar Summit, LLCILK2021-04-12
04714379292640MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-08-30
04714379292657MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-08-30
04714379292664MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-08-30
04714379292589MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-06-30
04714379292596MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-06-30
04714379292466MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-04-26
04714379292473MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-03-30
04714379292480MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-03-30
04714379292459MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2019-02-10
04714379292008MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2018-02-01
04714379292015MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2018-02-01
00817650023002PINNACLEHarmar Summit, LLCILK2018-01-04
00817650023019PINNACLEHarmar Summit, LLCILK2018-01-04
00817650022937PINNACLEHarmar Summit, LLCILK2017-09-26
00817650022852PINNACLEHarmar Summit, LLCILK2017-06-19
00817650022869PINNACLEHarmar Summit, LLCILK2017-06-19
00817650022876PINNACLEHarmar Summit, LLCILK2017-06-19
09120047770245LIFTKAR®Sano Transportgeraete GmbHILK2017-04-21
04714379291889MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2017-03-24
04714379291896MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2017-03-24
04714379291902MERITSMERITS HEALTH PRODUCTS CO., LTD.ILK2017-03-24
B24007Stair-PorterGaraventa (Canada) Ltd.ILK2016-09-28
B24008Evacu-TracGaraventa (Canada) Ltd.ILK2016-09-28
00817650022449PINNACLEHarmar Summit, LLCILK2016-09-28