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K Number
K032101
Device Name
POWERSTAND STAND-UP WHEELCHAIR
Manufacturer
THE STANDING CO., INC.
Date Cleared
2004-01-22

(198 days)

Product Code
IPL
Regulation Number
890.3900
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY, for users who have had, or may have in the future, positioning disorders relating to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair helps users with mobility.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Powerstand Stand-up Wheelchair." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
  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 document is solely focused on the FDA's determination of substantial equivalence for a physical medical device.

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).