FDA.reportPublic FDA data

Fusion

Primary DI
00606509200011
Brand
Fusion
Company
Pride Mobility Products Corp
Model
Fusion/R40
Catalog number
N/A
Device description
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606509200011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509200011006065092000116065092000110606509200011

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, non-collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device cannot be folded or readily dismantled for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041477449
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606509300919Go Go Super Portable 2SC15M2N/A2026-03-19
00606509300926Go Go Super Portable HDSC15HDN/A2026-03-19
00606509300865Baja Wrangler 3BA403N/A2026-02-17
00606509300872Ultra X GEN 3SC493N/A2026-02-17
00606509300889Elite Traveller GEN 3SC443EN/A2026-02-17
00606509300896Elite Traveller GEN 3 PlatinumSC443EMSN/A2026-02-17
00606509500418MM5401MM5401N/A2026-02-03
00606509500425MM5640MM5640N/A2026-02-03
00606509100403Jazzy EVO 613 AirJazzy EVO 613 AirN/A2025-11-14
00606509401685LC435PWLC435PWN/A2025-11-14
00606509100380Jazzy Carbon 27Jazzy Carbon 27N/A2025-10-10
00606509100397Jazzy Carbon HDJazzy Carbon HDN/A2025-10-10
00606509500401MM6420MM6420N/A2025-09-05
00606509100373Jazzy Carbon 27 XJazzy Carbon 27 XN/A2025-08-08
00606509500395MM8955MM8955N/A2025-08-07
00606509500326MM3600MM3600N/A2025-08-05
00606509500371MM8945MM8945N/A2025-08-05
00606509500388Rascal Carbon CruiserRascal Carbon CruiserN/A2025-05-15
00606509200288Q6 Edge 4Q6 Edge 4N/A2025-05-08
00606509300858Go Go Endurance AL+SC54ALXN/A2025-04-04

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
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
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
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531324MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531331MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531201MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-04-30