Astrotilt 98

GUDID B829981

PDG Product Design Group Inc

Push-rim manual wheelchair, non-bariatric
Primary Device IDB829981
NIH Device Record Key70651545-ba4d-4a8c-bdf3-aac7659305d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAstrotilt
Version Model NumberAstrotilt
Catalog Number98
Company DUNS253873905
Company NamePDG Product Design Group Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB829981 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IORWheelchair, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

Devices Manufactured by PDG Product Design Group Inc

B829281 - Fuze Manual Tilt Wheelchair2024-08-07
B829971 - Luna2023-06-15
B829981 - Astrotilt2023-06-15
B829981 - Astrotilt2023-06-15
B829991 - Eclipse 3502023-06-15
B829271 - Bentley Manual Tilt Wheelchair2022-09-09
B829101 - Bentley Manual Tilt Wheelchair2020-10-06
B829111 - Eclipse Bariatric Manual Wheelchair2020-10-06
B829121 - Stellar Manual Tilt Wheelchair2020-10-06

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