FDA.reportPublic FDA data

Astrotilt

Primary DI
B829981
Brand
Astrotilt
Company
PDG Product Design Group Inc
Model
Astrotilt
Catalog number
98
Published
2023-06-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K061475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061475000ASTROTILT MANUAL WHEELCHAIRPdg Product Design Group, Inc.2006-06-14IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B829981PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

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
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
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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M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31