Stellar LEAP Manual Tilt Wheelchair 5522

GUDID B829221

PDG Product Design Group Inc

Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
Primary Device IDB829221
NIH Device Record Keyf9dd8453-c920-433b-a1b1-07924c1e8fb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar LEAP Manual Tilt Wheelchair
Version Model NumberSTELLAR LEAP
Catalog Number5522
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

Customer Support Contacts

Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com
Phone888-858-4422
Emailinfo@pdgmobility.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB829221 [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 Date2020-10-06
Device Publish Date2020-09-28

Devices Manufactured by PDG Product Design Group Inc

B829281 - Fuze Manual Tilt Wheelchair2024-08-07
B829971 - Luna2023-06-15
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.