ELECTRO-LITE ELITE POWERED WHEELCHAIR

• K Number: K970575
• Device Name: ELECTRO-LITE ELITE POWERED WHEELCHAIR
• Manufacturer: DAMACO
• Date Cleared: 1997-08-05 ( 173 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For the non-ambulatory or mobility impaired individual.

Device Description

Electro-LiteEM® Powered Wheelchair

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair (Electro-LiteElite Powered Wheelchair II). This type of document confirms that a medical device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market.

However, a 510(k) letter does not typically contain the detailed information about acceptance criteria, device performance studies, and ground truth establishment that you've requested. These details are part of the original 510(k) submission made by the manufacturer to the FDA, which is a much more extensive document.

The provided text primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for further assistance.
• The stated "Indications For Use" for the device, which is "For the non-ambulatory or mobility impaired individual."

Therefore, based solely on the provided text, I cannot answer your questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. These details are not present in this regulatory correspondence.

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).