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K Number
K021145
Device Name
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
Manufacturer
MARKEN INTERNATIONAL, INC.
Date Cleared
2002-05-16

(37 days)

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

A mechanical wheelchair is indicated for persons restricted to a sitting position.

Conditions causing this would include but not be limited to arthritis, amputee, paraplegic, multiple sclerosis, polio, quadriplegic, cerebral palsy, spina bifida, head injury or trauma, muscular dystrophy, and geriatric conditions.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a mechanical wheelchair (Accommodator 2000X). The FDA has determined it is substantially equivalent to legally marketed predicate devices.

Based on the provided text, none of the requested information regarding acceptance criteria and studies are available.

This document is a regulatory letter from the FDA stating the substantial equivalence of the Accommodator 2000X mechanical wheelchair to predicate devices. It does not contain information about:

  1. Acceptance criteria and reported device performance: This document does not describe specific performance criteria or provide a table of performance metrics.
  2. Sample size and data provenance for a test set: No test set is mentioned, nor any details about sample size or data origin.
  3. Number of experts and qualifications for ground truth: No expert involvement or ground truth establishment is described.
  4. Adjudication method: Not applicable as no ground truth establishment is described.
  5. Multi-reader, multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
  6. Standalone (algorithm only) performance study: This is a mechanical device, not an algorithm, so this is not applicable.
  7. Type of ground truth used: No ground truth is mentioned.
  8. Training set sample size: No training set for an algorithm is mentioned.
  9. How ground truth for the training set was established: Not applicable.

The letter focuses solely on the regulatory approval process and the determination of substantial equivalence for a medical device that is a mechanical wheelchair. For mechanical devices, "acceptance criteria" typically refer to engineering specifications and testing against relevant standards (e.g., ISO for wheelchairs), which are not detailed in this FDA letter.

§ 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).