TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.

• K Number: K992310
• Device Name: TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
• Manufacturer: RUPIANI MEDICAL
• Date Cleared: 1999-11-02 ( 116 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

These devices are tricycles that are indicated for use with people, from children to adults, some of whom may have motor disabilities.

Device Description

These devices are tricycles

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "TONICROSS Tricycles." This document is a regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Regulation Number and Section

§ 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).