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K Number
K100824
Device Name
MECHANICAL WHEELCHAIR, MODEL DS 202-S
Manufacturer
SUZHOU KD MEDICAL
Date Cleared
2010-05-25

(62 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K082274
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

Device Description

DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about a study or acceptance criteria for an AI-powered device. Therefore, I cannot fulfill the request using the provided input.

The document is a standard 510(k) summary for a medical device (a manual wheelchair, Model DS 202-S) establishing substantial equivalence to a predicate device. It details:

  • Device Name: DS 202-S manual wheelchair
  • Intended Use: To provide mobility to physically challenged persons limited to a sitting position on flat and firm terrain, outdoor or indoor.
  • Classification: Class I, Mechanical wheelchair
  • Predicate Device: HUADONG HD11 manual wheelchair (K082274)
  • Non-Clinical Testing: The device meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec. 5, Sec. 8, Sec. 15, Sec. 15, Sec. 16 and California Bureau of Home Furnishings 117. These standards are for mechanical wheelchair performance and safety.

The request, however, asks for information typically associated with the validation of AI-powered medical devices, including acceptance criteria tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and details of comparative effectiveness studies (MRMC) or standalone performance studies. None of this information is present in the provided text as the device in question is a manual wheelchair, not an AI device.

§ 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).