FDA.reportPublic FDA data

e-fix®

Primary DI
04046727251055
Brand
e-fix®
Company
Alber GmbH
Model
E35/E36
Catalog number
1595695
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161241000e-fix E35/E36Alber GmbH2016-10-05ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046727251055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046727251055040467272510554046727251055

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair electric-motor-driven propulsion systemAn assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair).

Regulatory Flags#

DUNS number
340348858
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046727184476e-motion®M2515925202026-05-26
04046727184483e-motion®M2515925212026-05-26
04046727184490e-motion®M2515925222026-05-26
04046727248994e-fix®E35/E3615956242026-05-26
04046727250928e-fix®E35/E3615956812026-05-26
04046727250935e-fix®E35/E3615956822026-05-26
04046727250942e-fix®E35/E3615956832026-05-26
04046727250959e-fix®E35/E3615956842026-05-26
04046727250966e-fix®E35/E3615956862026-05-26
04046727250980e-fix®E35/E3615956872026-05-26
04046727250997e-fix®E35/E3615956882026-05-26
04046727251000e-fix®E35/E3615956892026-05-26
04046727251017e-fix®E35/E3615956912026-05-26
04046727251048e-fix®E35/E3615956932026-05-26
04046727166397e-fix®E35/E3615661802016-10-21
04046727166403e-fix®E35/E3615661812016-10-21
04046727167332e-fix®E35/E3615662822016-10-21
04046727167349e-fix®E35/E3615662832016-10-21
04046727167448e-fix®E35/E3615662932016-10-21
04046727167455e-fix®E35/E3615662942016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974842140160RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140177RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140504Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140566RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140580Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140641Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140665Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140726Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140740Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142102RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142119RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142126RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142140RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142072Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142089Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142096Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142133RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842141693Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-07
06974665661095EldHilfeYongkang Youha Electric Appliance Co.,LtdITI2026-06-24
06977027831099CHINFREANZhejiang Nysin Medical Co.,LtdITI2026-06-23
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
00860015909206VeloxVelox Manufacturing IncITI2026-05-28
06973134773017sliverfoxSilverfox Corporation LimitedITI2026-05-27
04046727184476e-motion®Alber GmbHITI2026-05-26
04046727184483e-motion®Alber GmbHITI2026-05-26
04046727184490e-motion®Alber GmbHITI2026-05-26
04046727248994e-fix®Alber GmbHITI2026-05-26
04046727250928e-fix®Alber GmbHITI2026-05-26
04046727250935e-fix®Alber GmbHITI2026-05-26
04046727250942e-fix®Alber GmbHITI2026-05-26