(35 days)
Not Found
No
The summary describes a manual wheelchair with no mention of AI or ML technology.
No
A therapeutic device is used to treat a disease or condition. This device provides mobility support and does not treat an underlying condition.
No
Explanation: The device description states that the TiLite Aero X is a "folding manual wheelchair" and its intended use is to "provide mobility to physically impaired individuals." There is no mention of diagnostic functions or capabilities.
No
The device description clearly states it is a folding manual wheelchair with physical components made of aluminum alloy, indicating it is a hardware device, not software-only.
Based on the provided information, the TiLite Aero X is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to physically impaired individuals." This describes a device used on a person for a physical function, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a "folding manual wheelchair" made of aluminum components. This is a mechanical device for mobility, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a disease or condition.
- Reagents, calibrators, or controls.
The TiLite Aero X is clearly a medical device intended for mobility assistance, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals. The TiLite Aero X folding manual wheelchair is intended for ongoing daily use.
Product codes
IOR
Device Description
The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.
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 TiLite Aero X will meet the requirements of ANSI/RESNA WC/Volume 1: 1998, Sections 1, 5, 7, 8, 16 and 93.
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
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
510(k) SUMMARY
SEP 2 1 2007
(As Required by 21 CFR 807.92(c))
Submitted By:
TiSport, LLC 1426 Fast Third Avenue Kennewick, WA 99337 Telephone: 509-586-6117 Telecopier: 509-586-2413
Contact Person:
Richard S. Forman, President & Chief Legal Officer
Date:
August 15, 2007
Trade Name of Device:
TiLite Aero X
Common Name of Device:
Folding Manual Wheelchair
Classification Name of Device:
Wheelchair, Mechanical (21 CFR 890.3850; Product Code IOR)
Classification of Device:
Class I
Panel:
Physical Medicine Prosthetic Devices
Legally Marketed Predicate for Claimed Substantial Equivalence:
Quickie 2HP (K890050) manufactured by Sunrise Medical, Inc., successor to Mobility Designs, Inc.
1
Description of Device:
The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.
Intended Use of Device:
The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals. The TiLite Aero X folding manual wheelchair is intended for ongoing daily use.
Target Patient Population:
The TiLite Aero X device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such specific medical conditions: Amputee; Arthritis; Arthrogriposis; Cerebral Palsy; Geriatric Conditions; Head Injury or Trauma; Hemiplegic; Multiple Sclerosis; Muscular Dystrophy; Paraplegic; Polio; Quadraplegic; Spina Bifida; Stroke/CVA; Tetraplegic; and other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis
Device Comparison:
There are no significant differences between the TiLite Aero X and the predicate device. The only apparent difference between the predicate device and the TiLite Aero X is that the TiLite Aero X offers the ability to customize and adjust the device to a greater degree than does the predicate device. The degree of customization and adjustment allows for a better opportunity to properly "fit" the user/operator of the wheelchair in a clinical setting and should permit better safety and access to the product's options and accessories. There are also certain technological differences between the TiLite Aero X and the predicate device that result in improved functionality. For example, the mechanism to add camber to the rear wheels uses camber plugs on the TiLite Aero X whereas the mechanism to add camber to the rear wheels uses washers on the predicate device. The mechanism to attach the front casters to the TiLite Aero X allows for a much greater degree of adjustability forward and rearward, whereas there are only two positions in which the front casters can be mounted on the predicate device.
Testing Results:
The TiLite Aero X will meet the requirements of ANSI/RESNA WC/Volume 1: 1998, Sections 1, 5, 7, 8, 16 and 93.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Public Health Service
SEP 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TiSport, LLC % Mr. Richard S. Forman President & Chief Legal Officer 1426 East Third Avenue Kenwick, WA 99337
Re: K072311
Trade/Device Name: TiLite Aero X Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 15, 2007 Received: August 17, 2007
Dear Mr. Forman:
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 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, RDA max 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. Your 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 eectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
3
Page 2 - Mr. Richard S. Forman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
TiLite Aero X
Indications for Use:
:
The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | Yes |
|---|---|
| ------------------------------------------------- | ----- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | Yes |
|---|---|
| ------------------------------------------------ | ----- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K072311 |
|---|---|
| --------------- | --------- |
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