CR45

GUDID 00850013379309

KI MOBILITY, LLC

Wheelchair, occupant-driven, rear-wheels-operated, non-collapsible
Primary Device ID00850013379309
NIH Device Record Key759638a5-130a-4962-a42c-1c6d028f0148
Commercial Distribution StatusIn Commercial Distribution
Brand NameCR45
Version Model NumberCR45
Company DUNS609305656
Company NameKI MOBILITY, LLC
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-Countertrue

Customer Support Contacts

Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone1-800-981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com
Phone+1(800)981-1540
Emailsales@kimobility.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013379309 [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 Date2022-08-09
Device Publish Date2022-08-01

Devices Manufactured by KI MOBILITY, LLC

00840363369099 - Axiom2025-09-08 Axiom PB Lateral Mount, Omnilink, Right
00840363369105 - Axiom2025-09-08 Axiom PB Lateral Mount, Omnilink, Left
00840363369112 - Axiom2025-09-08 Axiom PL Lateral Mount, Omnilink, Right
00840363369129 - Axiom2025-09-08 Axiom PL Lateral Mount, Omnilink, Left
00840363369136 - Axiom2025-09-08 Omnilink Swing Away, Fixed, Right
00840363369143 - Axiom2025-09-08 Omnilink Swing Away, Fixed, Left
00840363369150 - Axiom2025-09-08 Omnilink Swing Away, Swivel, Right
00840363369167 - Axiom2025-09-08 Omnilink Swing Away, Swivel, Left

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.