ELECTRO-LITE ELITE POWERED WHEELCHAIR by DAMACO

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body. The eagle's wings are represented by curved lines that also form the faces of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Higginbotham Quality Assurance Damaco 5105 Maureen Lane Moorpark, California 93021

AUG - 5 1997

Re : K970575 Electro-LiteElite Powered Wheelchair II Requlatory Class: Product Code: ITI Dated: June 13, 1997 Received: June 16, 1997

Dear Mr. Higginbotham:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Mr. Ron Higginbotham

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number: K970575

Device Name: Electro-LiteEM® Powered Wheelchair

Indications For Use:

For the non-ambulatory or mobility impaired individual.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONLANQTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devic 510(k) Number .

Prescription Use .Per 21 CFR 801.109) OR

Over-The Counter Use

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).