FDA.reportPublic FDA data

Jazzy Carbon 27

Primary DI
00606509100380
Brand
Jazzy Carbon 27
Company
Pride Mobility Products Corp
Model
Jazzy Carbon 27
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
2025-10-10
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220747000Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd2022-05-12ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606509100380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606509100380006065091003806065091003800606509100380

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

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
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
00606509500357Rascal ConquestRSC104N/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