(13 days)
Stair-Trac K981518
No
The description focuses on mechanical and electrical components for transporting a wheelchair and does not mention any AI or ML capabilities.
No
The device is described as a portable wheelchair lift for transporting individuals up and down stairs, not for diagnosing, treating, or preventing disease or affecting the structure or function of the body.
No
The device is described as a portable wheelchair lift designed to transport individuals up and down stairs, performing a mechanical function rather than diagnosing any medical condition.
No
The device description clearly outlines a physical, mechanical device with motors, batteries, tracks, a platform, and a hydraulic actuator, indicating it is a hardware-based medical device.
Based on the provided information, the Super-Trac TRE-52 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Super-Trac TRE-52 is a mechanical device used to transport individuals in wheelchairs. It does not interact with or analyze any biological samples.
- The intended use is for physical transportation. The description clearly states its purpose is to "mechanically transport a single individual in a wheelchair up and down stairs."
- The device description focuses on mechanical and electrical components. It details motors, batteries, tracks, platforms, and controls, all related to physical movement and operation.
- There is no mention of any biological analysis, testing, or diagnosis. The information provided does not include any elements related to medical testing or diagnostic procedures.
Therefore, the Super-Trac TRE-52 falls under the category of a medical device (specifically, a mobility aid or lift), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Super-Trac TRE-52 is intended to mechanically transport a single individual in a wheelchair up and down stairs in a private or public facility. The Super-Trac must be operated by a trained attendant.
Product codes
ING
Device Description
The Super-Trac TRE-52 is a portable wheelchair lift designed to carry a passenger in a wheelchair up and down stairs. It is a mobile, attendant-operated device that will accommodate most child and adult wheelchairs, including power wheelchairs and sports wheelchairs.
The Super-Trac TRE-52 consists of two endless durable belt tracks driven by two 12 volt DC motors. Two 12 volt 24 AH rechargeable batteries are used to power the motors. The device includes a set of auxiliary wheels that assist in maneuverability on landings.
The wheelchair fits onto a platform that is mounted to the drive frame. Loading is by means of an integrated ramp that slides out from below the platform. The wheelchair is secured to the platform using four tie-down straps and a seatbelt that goes around both the passenger and wheelchair. The platform is tilted to the stair-travel position by a hydraulic actuator located on the drive frame.
Super-Trac is equipped with a key switch to restrict use to authorized persons. A stair-slope indicator is provided to determine the stair angle is within the operating range.
The attendant operates Super-Trac TRE-52 from controls located on the operating handle. Super-Trac TRE-52 is designed for use on both indoor and outdoor stairways.
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
most child and adult wheelchairs
Intended User / Care Setting
trained attendant / private or public facility
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)
Stair-Trac K981518
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
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.
0
3. Summary
APR = 4 2002
Portable Wheelchair Lift
K020933
page 1 of 3
Common Device Name:
Trade Name:
Super-Trac TRE-52
Predicate Device:
Stair-Trac K981518
Device Description:
The Super-Trac TRE-52 is a portable wheelchair lift designed to carry a passenger in a wheelchair up and down stairs. It is a mobile, attendant-operated device that will accommodate most child and adult wheelchairs, including power wheelchairs and sports wheelchairs.
The Super-Trac TRE-52 consists of two endless durable belt tracks driven by two 12 volt DC motors. Two 12 volt 24 AH rechargeable batteries are used to power the motors. The device includes a set of auxiliary wheels that assist in maneuverability on landings.
The wheelchair fits onto a platform that is mounted to the drive frame. Loading is by means of an integrated ramp that slides out from below the platform. The wheelchair is secured to the platform using four tie-down straps and a seatbelt that goes around both the passenger and wheelchair. The platform is tilted to the stair-travel position by a hydraulic actuator located on the drive frame.
Super-Trac is equipped with a key switch to restrict use to authorized persons. A stair-slope indicator is provided to determine the stair angle is within the operating range.
The attendant operates Super-Trac TRE-52 from controls located on the operating handle. Super-Trac TRE-52 is designed for use on both indoor and outdoor stairways.
See attached brochure.
1
Image /page/1/Picture/0 description: The image shows the logo for Garaventa Stair-Trac, a portable wheelchair lift. The logo is in a bold, shadowed font. The image also contains handwritten text at the top right corner, which appears to be a document number and page number, specifically KONO933 and page 2 of 3.
Image /page/1/Picture/2 description: In the image, two people are on a stair lift. The person in the front is operating the stair lift, and the other person is standing next to the stairs. The stair lift is designed to help people with disabilities to go up and down stairs. There is a sign on the bottom left of the image that indicates that the area is accessible to people with disabilities.
The Garaventa Stair-Trac is an easy to use, portable wheelchair lift designed to attach under most manual wheelchairs. Stair-Trac's powerful motor allows a small attendant to safely transport a larger passenger up and down stair-Trac is suitable for indoor or outdoor use in public buildings and private homes. An affordable and reliable portable access solution.
Image /page/1/Picture/4 description: The image is a logo for Garaventa Accessibility. The logo is black and white and features the word "GARAVENTA" in a bold, sans-serif font. Above the word is a semi-circular shape with lines radiating outward. Below the word "GARAVENTA" is the word "ACCESSIBILITY" in a smaller font. At the bottom of the logo is the website address "www.garaventa.ca".
7(4)
2
Specifications
Load Capacity ... ... 130kg 285lbs Power Capacity . . . . . . . . . 650 stairs Maximum Speed
Up Stairs Down Stairs - 12.5m (41.0ft)/mir 12 VDC 12. ........ 12 VDC Motor Batteries . . . . . . . . . 2 x 6V - 20AH Max Charge Rate .... ............. 4 amp Optimum Stair Angle ....
Dimensions
Height 935mm 36.8ir Depth 1473mm 58.0ir Width 635mm 25 Oir
Weight
| Drive Frame | 39kg/86lb |
|---|---|
| Support Handle | 15kg/33lb |
| Total Weight | 54kg/119lb |
Clearances
Wheelchair loading/unloading requires a minimum straight line clearance of approximately 3m/10f The diagram below shows typical clearances required on turnback stairways Dimensions vary with stairway width and operator expenence. Consult Garaventa or your local representative for oparance versication
Image /page/2/Figure/9 description: The image shows a technical drawing with dimensions. The top part of the drawing indicates a length of 2250mm or 88.6in and a height of 1300mm or 51.18in. The bottom part of the drawing shows two sections, each with a length of 915mm or 36.0in.
Garaventa Accessibility
PO Brx 1769 B The WA 98231-1760
505 134A Street Surrey, BC Canada V3W 7B3 -604) 594-0422 To Free -- 800-663-6556 - 6041 594-9915 ww.garaventa.ca
FEV (1 23 /
Image /page/2/Picture/15 description: In the image, a person is standing next to a wheelchair. The person appears to be interacting with the wheelchair, possibly assisting someone or adjusting it. The scene is set outdoors, with steps and a platform visible in the background, suggesting a public space or building entrance.
Attach the Stair-Trac to the wheelchair, recline the passenger and move them to the stairway.
Image /page/2/Picture/17 description: In the image, a person is pushing another person in a wheelchair up a set of stairs. The person in the wheelchair is facing forward, and the person pushing the wheelchair is behind them. The stairs are made of concrete, and there is a building in the background. The image is in black and white.
Ascend or descend stairs with the press of a button. The passenger sits in a comfortable, upright position.
Image /page/2/Picture/19 description: In the image, a person is loading an object into the back of a car. The car's trunk is open, and the person is standing behind the car. The person is wearing a hat and a jacket. The object being loaded appears to be a piece of equipment with wheels. The background is blurry, but it appears to be a street or parking lot.
The Stair-Trac is easy to load into vehicles using the optional loading ramp, and fits easily into most car trunks.
cd0933 page 3 of 3
Features
- · Attaches to most standard wheelchairs with push handles (adult/child)
- Powered to carry over 250 lbs. up approximately 30 floors
- · Use on virtually any indoor or outdoor stairway
- · Stable and self-supporting
- · Durable tracks grip stairs securely
- · Detachable support handle for compact storage and easy transport
- · Quick-release safety belt
- · Key switch restricts use to authorized persons
- · Optional auxiliary seat for non-wheelchair passengers
- · Rechargeable batteries and charger
Benefits
- · Economical compared to stairway lifts and elevators
- Can be used on various stairways within a building
- · Can be used when electrical pov fails or is not available
- Easily stores in a secure area when not in use
- · Requires minimal maintenance
- · Available immediately
What our customers say
"The Garaventa Stair-Trac has allower our District to meet its needs at a fraction of the cost of installing an elevator in our building."
- Batavia City Schools, Batavia, N\
"It has proven to be dependable, safe, and functional for our school district." - Hillcrest Elementary, American Falls, II
Coming soon...The Super-Trac
The portable wheelchair lift for custom and power wheelchairs. Available April, 2002
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem that resembles a bird or a symbol of human services, with flowing lines and curves.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2002
Mr. Norm Cooper Director of Sales & Marketing Garaventa Accessibility P.O. Box 1769 Blaine, Washington 98231-1769
Re: K020933
Trade/Device Name: Garaventa Super-Trac TRE-52 Portable Wheelchair Lift Regulation Number: 890.3930 Regulation Name: Wheelchair Elevator Regulatory Class: Class II Product Code: ING Dated: March 20, 2002 Received: March 22, 2002
Dear Mr. Cooper:
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 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) 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 r ou may , arores or visions 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.
4
Page 2 - Mr. Norm Cooper
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will and will would be finding of substantial equivalence of your device to a legally premaired notification - The sification 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 21 CFR Part 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 Compliance at (30) 57 contact the Office of Compliance at (301) 594-4639. Also, please note the your actived, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
L. Mark N. Millhouser
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
5
Statement of Indications For Use
K020933 510(k) Number:
Device Name:
Super-Trac TRE-52
Portable Wheelchair Lift
Indications for Use:
The Super-Trac TRE-52 is intended to mechanically transport a single individual in a wheelchair up and down stairs in a private or public facility. The Super-Trac must be operated by a trained attendant.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
4144444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number.
Prescription Use
(Per 21 C.F.R Section 801.109)
OR
Over-the-Counter Use __