FDA.reportPublic FDA data

Elevation Ultralight Manual Wheelchair

Primary DI
B829201
Brand
Elevation Ultralight Manual Wheelchair
Company
PDG Product Design Group Inc
Model
ELEVATION
Catalog number
5520
Published
2020-09-28
Public version status
Update
Distribution status
Not 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
K140023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140023000ELEVATIONPdg Product Design Group, Inc.2014-10-16IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B829201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, 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 manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device cannot be folded or readily dismantled for transport.

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
B829221Stellar LEAP Manual Tilt WheelchairSTELLAR LEAP55222020-09-28
B829281Fuze Manual Tilt WheelchairFUZE M5055282024-07-30
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
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
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
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31