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K Number
K250027
Device Name
Powered Mobility Scooter
Manufacturer
Intradin (Shanghai) Machinery Co., Ltd
Date Cleared
2025-02-21

(46 days)

Product Code
INI
Regulation Number
890.3800
Type
Special
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Powered Mobility scooteris intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Powered Mobility Scooter

AI/ML Overview

I am sorry, but the provided text from the FDA letter (K250027) does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a clearance letter for a "Powered Mobility Scooter," a Class II medical device. It primarily covers:

  • The FDA's determination of substantial equivalence to a predicate device.
  • Regulatory requirements and general controls applicable to the device (e.g., Quality System Regulation, UDI Rule, adverse event reporting, labeling).
  • Standard disclaimers regarding FDA's review and the manufacturer's responsibility for compliance.
  • The "Indications for Use" for the device, stating it is "intended for medical purposes to provide mobility to persons restricted to a sitting position."

The letter does not include details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for a test set or data provenance of a study.
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication methods.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for training sets.
  9. How ground truth for training data was established.

These details are typically found in the 510(k) submission itself (the "premarket notification"), which is a much more extensive document than the FDA's clearance letter. The clearance letter only announces the outcome of the FDA's review of that submission.

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

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).