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K Number
K080373
Device Name
TACAHE PC1350 POWER WHEELCHAIR
Manufacturer
DALTON MEDICAL CORP.
Date Cleared
2008-04-14

(62 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the Tacahe PC1350 is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

Tacahe PC1350 Power Wheelchair

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the Dalton Medical Corp. Tacahe PC1350 Power Wheelchair. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results and acceptance criteria for a new AI or diagnostic device.

Therefore, the document does not contain the information requested regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study or AI improvement effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This is a regulatory document confirming clearance based on substantial equivalence, not a clinical or performance study report.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).