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K Number
K981418
Device Name
TC SERIES (TRANSPORT)
Manufacturer
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC.
Date Cleared
1998-06-10

(51 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Transport) are not for self-propelling but, to be propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.

Device Description

TC Series (Transport) [Mechanical Wheelchair]

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of mechanical wheelchairs. It confirms the substantial equivalence of these devices to previously marketed devices and permits marketing.

The document does not contain any information about:

  • Acceptance criteria for device performance.
  • A study proving the device meets acceptance criteria.
  • Sample sizes, data provenances, expert qualifications, or adjudication methods for a test set.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Training set sample size or how ground truth was established for a training set.

Therefore, I cannot fulfill your request based on the provided input.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).