Y.E.S. POWERED WHEELCHAIR, MODEL T200

• K Number: K032669
• Device Name: Y.E.S. POWERED WHEELCHAIR, MODEL T200
• Manufacturer: YEOU EIR SHUEN MACHINERY CO., LTD.
• Date Cleared: 2003-11-12 ( 76 days)
• Product Code: ITN , ITI
• Regulation Number: 890.3675
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Y.E.S. Powered Wheelchair, T200

AI/ML Overview

I am sorry, but the provided text does not contain information on acceptance criteria, study details, or device performance for the Y.E.S. Powered Wheelchair, T200. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include the specifics of performance testing or clinical studies.

Regulation Number and Section

§ 890.3675 Denis Brown splint.

(a)
Identification. A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.