(138 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, or related concepts like image processing, deep neural networks, or performance metrics typically associated with AI/ML models. The description focuses solely on the intended use and user population for a mobility device.
No
The device is intended to enhance personal mobility, which is generally assistive rather than therapeutic. While it can be used by individuals with certain medical conditions, its primary function is to aid movement, not to treat or cure disease.
No
Explanation: The device is described as enhancing personal mobility for users with walking difficulties, not for diagnosing diseases or conditions.
No
The provided 510(k) summary only describes the intended use of a device related to personal mobility. It lacks any description of the device itself, including whether it is hardware, software, or a combination. Without a device description, it's impossible to determine if it's a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enhance personal mobility" for individuals with various physical limitations. This is a physical aid, not a diagnostic tool.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, tissue) or to provide information about a person's health status or disease.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from diagnostic purposes.
- No Mention of Diagnostic Technologies: There is no mention of image processing, AI, DNN, ML, or any other technology typically associated with diagnostic devices.
- No Mention of Biological Samples or Analysis: The description focuses on physical mobility and the conditions that might necessitate such a device, not on analyzing biological samples.
In summary, the device's purpose is to assist with physical movement, which is fundamentally different from the function of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
INI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a stylized image of an eagle.
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.
1
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 (301) 597-1037. The Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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)
3
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)
4
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)