FDA.reportPublic FDA data

e-fix®

Primary DI
04046727250942
Brand
e-fix®
Company
Alber GmbH
Model
E35/E36
Catalog number
1595683
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
04046727250942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046727250942040467272509424046727250942

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
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
04046727251055e-fix®E35/E3615956952026-05-26
04046727210960e-motion®M252022-09-26
04046727210977e-motion®M252022-09-26
04046727210984e-motion®M252022-09-26
04046727210991e-motion®M252022-09-26
04046727211004e-motion®M252022-09-26
04046727211028e-motion®M252022-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04046727250959e-fix®Alber GmbHITI2026-05-26
04046727250966e-fix®Alber GmbHITI2026-05-26
04046727250980e-fix®Alber GmbHITI2026-05-26
04046727250997e-fix®Alber GmbHITI2026-05-26
04046727251000e-fix®Alber GmbHITI2026-05-26
04046727251017e-fix®Alber GmbHITI2026-05-26
04046727251048e-fix®Alber GmbHITI2026-05-26
04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
06976245010378Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06973175531164Ranger SpaceproAnhui JBH Medical Apparatus Co., Ltd.ITI2026-03-21
00810203610940ComfyGOComfyGO, IncITI2026-03-10
06977027830917A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830924A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830931A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
G450ARK5500FOLD & GO WheelchairsOnekubed Designs LLCITI2026-02-27
04719873856701KarmaKARMA MOBILITY COMPANY LIMITEDITI2026-02-25
06972665816019Nanjing Kangni Smart Technology Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.ITI2026-02-11