(133 days)
No
The description details a standard electric scooter with mechanical and electrical components, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The document describes a mobility scooter designed to enhance user mobility, which falls under the category of durable medical equipment rather than a therapeutic device that provides unique medical therapy or treatment.
No
The device description indicates that the scooter is designed to enhance user mobility and does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines a physical, electrically-powered scooter with multiple hardware components (seat, frame, motor, batteries, wheels, etc.). It is not solely software.
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 user mobility" for individuals with walking difficulties or those who prefer to ride. This is a functional, mobility-assisting purpose, not a diagnostic one.
- Device Description: The description details a physical, electrically-powered scooter with components related to movement, steering, power, and braking. There are no components or functions described that would involve testing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic claims.
- Use in a laboratory or clinical setting for diagnostic purposes.
The device is clearly a mobility aid, as further supported by the predicate device being another scooter.
N/A
Intended Use / Indications for Use
The scooter is designed to enhance user 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 who simply prefer to ride but can, if need be, walk.
The Golden Technologies, Inc Golden Hawk is designed to enhance user 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 who simply prefer to ride but can, if need be, walk
Product codes
89INI
Device Description
This is a modular electrically-powered scooter including as modular components a seat, seat post, main front frame and, motor assembly, removeable rear plastic body and 2-12VDC batteries connected in series to provide a 24VDC power source The scooter is built in a manner allowing quick and easy assembly/disassembly
The mainframe includes a rotably-affixed front wheel and tiller for steering, a seat post pedestal I he maintrains modules a panel with direction/speed control, a headlight, a rear half weldment (anti-ip wheelie bars and leaf springs) hinged to main floor pan and a latch/receiver mechanism to capture motor assembly locking bar. The motor assembly includes a pair of rear wheels coupled to a transaxle which is driven by an electric motor. The motor assembly also includes an electric brake, motor control board, battery charger, 2-12VDC batteries, a battery tray and a connector panel for battery and control signal cable hook-ups. The motor assembly is secured to main front frame by threading motor carriage pins just under rear weldment leaf springs, rotating motor assembly to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, insert seat post into seat pedestal (receiver), hold latch in a "locked" upright position.
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)
The scooter has been tested to the following standards: UL Listed 9F15 Battery charger ISO 01 (Static Stability) - ISO/CD 7176-1:1995-05-03 (E) (See Section 6A for results) ISO 02 (Dynamic Stability) ISO 7176-2:Draft 1996-02-09 (See Section 6A for results) EMC Evaluation in accordance with the Draft ISO EMC Addition to IS 7176-14 ENSSOII Radiated emissions PASS ENSSO! ! PASS WITH FIX Conducted emissions IEC 801-2 Electrostatic Discharge Immunity PASS IEC 1000-4-3 Radiated Electric Field Immunity (Draft) PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/4 description: The image shows the logo for "Golden Technologies, inc.". The word "Golden" is in large, bold, and slightly slanted font. Below "Golden" is the word "Technologies" in a similar font, but smaller. To the right of "Technologies" is ", inc." in a smaller, handwritten-style font.
K971043
aug. 1, 1997
11:41
401 Bridge Street Old Forge, PA 18518 (717) 451-7477 - Fax (717) 451-7494 HTTP://www.GoldToch.com
510(k) SUMMARY
This 510(k) Summary is submitted, in conjunction with a full submission, this 19th 1. day of March, 1997, by:
Chris McConnell Director of Operations/Engineering Scooter Division Golden Technologies 401 Bridge Street Old Forge, PA 18518
Telephone: 717-498-6962 717-451-7477 x 241 (Chris McConnell) 717-451-7477 x 232 (Fred Kiwak) Fax: 717-451-7494
2. The device is as follows:
Trade name: Golden Eagle GT2000 Common Name: Motorized 3-wheeled vehicle Classification Name: Motorized electric 3-wheeled vehicle (per 21 CFR 890.3800) Class II 89INI
Predicate device on which we base equivalence: 3.
Pride Health Care Legend Scooter (K926295) Product Code 89INI
র্ব. Description of Device:
This is a modular electrically-powered scooter including as modular components a seat, seat post, main front frame and, motor assembly, removeable rear plastic body and 2-12VDC batteries connected in series to provide a 24VDC power source The scooter is built in a manner allowing quick and easy assembly/disassembly
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The mainframe includes a rotably-affixed front wheel and tiller for steering, a seat post pedestal I he maintrains modules a panel with direction/speed control, a headlight, a rear half weldment (anti-ip wheelie bars and leaf springs) hinged to main floor pan and a latch/receiver mechanism to capture motor assembly locking bar.
The motor assembly includes a pair of rear wheels coupled to a transaxle which is driven by an electric motor. The motor assembly also includes an electric brake, motor control board, battery charger, 2-12VDC batteries, a battery tray and a connector panel for battery and control signal cable hook-ups.
The motor assembly is secured to main front frame by threading motor carriage pins just under rear weldment leaf springs, rotating motor assembly to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, insert seat post into seat pedestal (receiver), hold latch in a "locked" upright position.
Intended use of the device 4.
The scooter is designed to enhance user 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 who simply prefer to ride but can, if need be, walk.
ડ. Similarities and Differences to predicate device Similarities
- The "Golden Eagle" and "Legend" scooters both use a 24VDC permanent magnet motor .............................................................................................................................................................................. attached to a transaxle drive unit.
-
- Both use a disc-type coil-activated electric brake.
- רי The motor control boards are of the same basic design and concept.
- ণ Each has an industry-typical wig-way potentiometer, forward/reverse speed control, along with a speed limit potentiometer
- Both scooters feature upholstered seats with removable arms and height adjustment capability. vi Seats on each swivel 360°
- Each uses 2 12VDC U-1 type batteries as their power source, and each uses a commercially 6. available built-in charger to replenish depleted batteries.
-
- All major dimensions are similar
- The "control panel" on each has a voltage meter, horn switch and speed limit potentioneter 8.
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357
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| Differences | ||
|---|---|---|
| Legend | Golden Eagle | |
| Suspension | No suspension system | Leaf springs near rear of |
| scooter and coil springs on | ||
| the front fork | ||
| Tires | Pneumatic tires | Solid tires (no flats) |
| Wig-wag paddle controls | Lower thumb type only | Upper and lower wig-wag |
| paddle controls | ||
| Seat post | Tube with clevice pin | |
| height adjustment | Gas-filled for auto height | |
| adjustment and cushioned | ||
| ride. | ||
| Lights | None | Standard front safety light |
| Seat pedestal | Mounts on back of scooter | |
| Batteries on front half | Mounts on front of scooter | |
| Batteries on rear motor assb |
6. Safety and Effectiveness Information
The scooter has been tested to the following standards:
UL Listed 9F15 Battery charger ISO 01 (Static Stability) - ISO/CD 7176-1:1995-05-03 (E) (See Section 6A for results) ISO 02 (Dynamic Stability) ISO 7176-2:Draft 1996-02-09 (See Section 6A for results) EMC Evaluation in accordance with the Draft ISO EMC Addition to IS 7176-14 ENSSOII Radiated emissions PASS ENSSO! ! PASS WITH FIX Conducted emissions IEC 801-2 Electrostatic Discharge Immunity PASS IEC 1000-4-3 Radiated Electric Field Immunity (Draft) PASS
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38
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Image /page/3/Picture/2 description: The image shows a partial logo of the Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The image is cropped, showing only the right side of the logo and a portion of the text surrounding it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris McConnell Golden Technologies, Inc. 401 Bridge Street Old Forge, Pennsylvania 18518
Re : K971043 Golden Eaqle GT2000 K971050 Golden Hawk Regulatory Class: II Product Code: INI Dated: May 28, 1997 Received: May 30, 1997 AUG - 1 1997
Dear Mr. McConnell:
We have reviewed your Section 510 (k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices 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.
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Page 2 - Mr. Chris McConnell
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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 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,
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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SECTION 3
DEVICE DESCRIPTIVE INFORMATION
Intended Use SECTION 3A
The Golden Technologies, Inc Golden Hawk is designed to enhance user 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 who simply prefer to ride but can, if need be, walk
scolpo
(Division Sign-Off)
Division Restorative Devices
510(k) Number KA71050
Over-the-Counter Use