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K Number
K022697
Device Name
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
Manufacturer
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
Date Cleared
2003-01-24

(164 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
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

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a powered wheelchair. It does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis indicates that the letter confirms the device (Teh Lin Jupiter Power Chair, TL-320) is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The letter is a regulatory approval, not a technical report detailing performance testing.

Therefore, I cannot provide the requested information. The document does not contain details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. A multi-reader multi-case (MRMC) comparative effectiveness study.
  6. A standalone (algorithm only) performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).