Search Results
Found 1 results
510(k) Data Aggregation
K Number
K022699Device Name
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIRManufacturer
Date Cleared
2002-09-13
(31 days)
Product Code
Regulation Number
890.3850Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
TRANSFER COMPANION HR3000 MANUAL WHEELCHAIR
AI/ML Overview
The provided document is a 510(k) premarket notification letter from the FDA for a manual wheelchair. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device.
Therefore, I cannot provide the requested information based on the given input.
Ask a Question
Ask a specific question about this device
Page 1 of 1