COMPANION MODEL 221, 321, 421

K012258 · Golden Technologies, Inc. · INI · Dec 3, 2001 · Physical Medicine

Device Facts

• Record ID: K012258
• Device Name: COMPANION MODEL 221, 321, 421
• Applicant: Golden Technologies, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

Device Story

Companion 221, 321, and 421 are motorized three-wheeled vehicles designed to enhance personal mobility. Operated by the user, these devices provide transportation for individuals with physical impairments affecting gait or endurance. The device functions as a powered mobility aid, allowing users to navigate environments where walking is difficult or impossible. By providing a stable, motorized platform, the device enables independent movement, reducing physical strain and improving accessibility for patients with conditions like arthritis, paralysis, or orthopedic injuries. The device is intended for use in various settings to facilitate daily activities and personal independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; intended for personal mobility; class II device; product code INI.

Indications for Use

Indicated for individuals with mobility impairments, including those unable to walk but capable of transferring, those with walking difficulties, or those preferring to ride due to conditions such as arthritis, leg/foot injury, severe back impairment, or paralysis.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Golden Technologies, Inc Mr. Fred Kiwak 401 Bridge Street Old Forge, Pennsylvania 18518

Re: K012258

Trade Name: Companion 221, 321, 421 Regulation Number: 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: II Product Code: INI Dated: November 5, 2001 Received: November 5, 2001

Dear Mr. Kiwak

We have reviewed your Section 510(k) premarket 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 May 20, 1910, the charce 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, (100) that ao not require spec subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, oontons provisions oractice, 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 If your device is classino a controls. Existing major regulations affecting your device can may oe subject to back acceral 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 I toase of action that I Brinination that your device complies with other requirements of the Act that I Drinas Intact a and regulations administered by other Federal agencies. You must or uny 1 oderal butther and eagliements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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 - Mr. Fred Kiwak

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ocgin maine of substantial equivalence of your device to a legally premarket notification: "The PDF micing of casionalisms of 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 II you desire specific advice to: your witto diagnostic devices), please contact the Office of additionally 21 CFR Fall 607.10 for his raily, for questions on the promotion and advertising of Compliance at [phone]. The Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionmation on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark n Millerson

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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510(k) Number (if known): , __ K012258

Device Name: Companion 321

Indications For Use:

The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

fo Mah n Melkein
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K012258

Prescription Usc (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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510(k) Number (if known): ________K012258_

Device Name: Companion 221

## Indications For Use:

The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis , leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*for*

| (Division Sign-Off) |
|----------------------------------|
| Division of General, Restorative |
| and Neurological Devices |

| 510(k) Number | K012258 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR |
|------------------|----|
|------------------|----|

(Per 21 CFR 801.109)

OK

Over-The-Counter Use

(Optional Format 1-2-96)

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510(k) Number (if known): ____ K012258_

Device Name: Companion 421

Indications For Use:

The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|-----------------------------------------------------------|---------|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K012258 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

(Optional Format 1-2-96)