FDA.report

e-fix®

Primary DI
04046727251017
Brand
e-fix®
Company
Alber GmbH
Model
E35/E36
Catalog number
1595691
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

Related Records

Product Codes

CodeName
ITIWheelchair, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K161241000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K161241000e-fix E35/E36Alber GmbH2016-10-05ITI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046727251017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046727251017040467272510174046727251017

GMDN Terms

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 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
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 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
04046727250942e-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
04046727251048e-fix®Alber GmbHITI2026-05-26
04046727251055e-fix®Alber GmbHITI2026-05-26
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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
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06973175531164Ranger SpaceproAnhui JBH Medical Apparatus Co., Ltd.ITI2026-03-21
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06977027830917A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830924A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830931A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
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