FDA.reportPublic FDA data

Fuze Manual Tilt Wheelchair

Primary DI
B829281
Brand
Fuze Manual Tilt Wheelchair
Company
PDG Product Design Group Inc
Model
FUZE M50
Catalog number
5528
Published
2024-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063736000FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50Pdg Product Design Group, Inc.2007-01-17IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B829281PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-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 by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-858-4422info@pdgmobility.com

Regulatory Flags#

DUNS number
253873905
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B829971LunaLuna972023-06-07
B829981AstrotiltAstrotilt982023-06-07
B829991Eclipse 350Eclipse 350992023-06-07
B829121Stellar Manual Tilt WheelchairSTELLAR55122020-09-28
B829161Fuze Manual Tilt WheelchairFUZE T2055162020-09-28
B829201Elevation Ultralight Manual WheelchairELEVATION55202020-09-28
B829221Stellar LEAP Manual Tilt WheelchairSTELLAR LEAP55222020-09-28
B829271Bentley Manual Tilt WheelchairBENTLEY LT-R55272022-09-01
B829101Bentley Manual Tilt WheelchairBENTLEY55102020-09-28
B829111Eclipse Bariatric Manual WheelchairECLIPSE55112020-09-28
B829151Fuze Manual Tilt WheelchairFUZE T5055152020-09-28
B829171Fuze Manual Tilt WheelchairFUZE JR55172020-09-28
B829191Stellar Manual Tilt WheelchairSTELLAR GL55192020-09-28
B829211Stellar Manual Tilt WheelchairSTELLAR HD55212020-09-28
B829231Stellar Manual Tilt WheelchairSTELLAR IMPACT55232020-09-28
B829241Bentley Manual Tilt WheelchairBENTLEY LT55242020-09-28
B829251Stellar Manual Tilt WheelchairSTELLAR GLT55252020-09-28
B829261Fuze Manual Tilt WheelchairFUZE T50N55262020-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
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06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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