K041186 · Afikim Electric Vehicles · ITI · Sep 9, 2004 · Physical Medicine
Device Facts
Record ID
K041186
Device Name
CADDY
Applicant
Afikim Electric Vehicles
Product Code
ITI · Physical Medicine
Decision Date
Sep 9, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3860
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with mobility problems. Mobility problems are generally problems with walking or with the stamina. It is suitable for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.
Device Story
CADDY is a transportable, foldable electric scooter; designed for elderly or physically disabled individuals with mobility or stamina deficits. Device features a foldable/disassemblable frame for ease of handling and transport. Operated by the user to assist with mobility in and around the home or during travel. Provides powered locomotion; replaces or augments walking. No complex electronic processing or software described.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Powered electric scooter; foldable and disassemblable frame design. Energy source: electric battery. Intended for indoor and outdoor (trip) use. No software or complex algorithmic components described.
Indications for Use
Indicated for elderly or physically disabled persons with mobility or stamina limitations affecting walking. Intended for use in and around the home and for transport during trips.
Regulatory Classification
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.
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 9 2004
Avner Fishbein Afikim Electric Vehicles Kibbutz Afikim 15148 Israel
Re: K041186 Trade/Device Name: CADDY Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 6, 2004 Received: August 13, 2004
Dear Mr. Fishbein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass been a lor 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Avner Fishbein
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotel with at a so the finding of substantial equivalence of your device to a legally premailer notification. The 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), please If you desire specific as no and (301) 594-4659. Also, please note the regulation entitled, Connect the Ories of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micromational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): K041186
CADDY Device Name:
Indications for Use:
The Caddy is a transportable / foldable electric scooter.
The Caddy Scooter has been developed especially for those people with The Caddy Books. Mobility problems are generally problems with walking or with the stamina.
wanting or was as a suite for the use of elderly persons and physically disabled persons.
The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.
Mark N. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K041186
mber
510(k) Number_
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
