FDA.report

Power Wheelchair

Primary DI
06976245010378
Brand
Power Wheelchair
Company
ZheJiang J&J Mobility Co., Ltd
Model
JJW-7004
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
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ITIWheelchair, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K253849000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253849000Electric wheelchair (JJW-7002, JJW-7003)ZheJiang J&J Mobility Co., Ltd.2026-03-20ITI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976245010378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976245010378069762450103786976245010378

GMDN Terms

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
446840475
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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Primary DIBrandModelCatalogPublished
06976245010361Power WheelchairJJW-70032026-05-26
06976245010187Power WheelchairJJW-60012026-05-25
06976245015564Power WheelchairJJW-60012025-11-18

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