(7 days)
Not Found
No
The description focuses on mechanical components (frame, actuators, switches) and basic powered movement (tilt/recline) for pressure relief. There is no mention of AI, ML, data processing, or any intelligent decision-making capabilities.
Yes
Explanation: The device is intended to provide pressure relief, which is a therapeutic benefit, to persons confined to a wheelchair by allowing tilting and reclining of the seat and back.
No
The device is described as a "battery powered, motorized seating system" that provides "pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back." Its intended function is therapeutic (pressure relief and positional changes), not diagnostic.
No
The device description explicitly states it is a "battery powered, motorized seating system" and lists hardware components such as a main frame assembly, system mounting plate, linear actuators, and a toggle switch assembly. This indicates it is a hardware device with potential software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide pressure relief to wheelchair users by tilting and reclining the seat and back. This is a mechanical function related to patient positioning and comfort, not the diagnosis of disease or other conditions.
- Device Description: The description details a mechanical system with a frame, mounting plate, actuators, and a switch. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
The device is clearly a medical device, but its function is related to patient support and positioning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.
The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
Product codes
ITI
Device Description
The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.
The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.
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)
Stealth Products has conducted performance and functional testing on the Stealth Products Powered Seating System. In all cases, the Stealth System passed its' performance requirements and met specifications.
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
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).
0
FEB 1 1 2005
510(k) Premarket Notification
Powered Seating System
K 050264
510(k) SUMMARY
STEALTH PRODUCTS POWERED SEATING SYSTEM FOR POWERED WHEELCHAIRS
Submitter
Stealth Products, Inc. 103 John Kelly Drive P.O. Box 468 Burnet, Texas 78611 Phone: (800) 965-9229 Fax: (800) 806-1225
Contact Person
Edward A. Kroll President Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124
Date Prepared: February 1, 2005
Name of Device
Stealth Products Powered Seating System for Power Wheelchairs
Common or Usual Name
Power Wheelchair Seating System
Classification Name
Wheelchair, Powered
Predicate Devices
Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).
1
Intended Use
The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.
Device Description
The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.
The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.
The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.
Substantial Equivalence
The Stealth Products Powered Seating System is substantially equivalent to Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and the Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).
Performance Data
Stealth Products has conducted performance and functional testing on the Stealth Products Powered Seating System. In all cases, the Stealth System passed its' performance requirements and met specifications.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stealth Products, Inc. C/o Edward A. Kroll President, Representative Consultant Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141
Re: K050264
Trade/Device Name: Stealth Products Powered Seating System for Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 2, 2005 Received: February 4, 2005
Dear Mr. Kroll:
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 for abo cased or 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, 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.
3
Page 2 - Mr. Kroll
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to cognifinding of substantial equivalence of your device to a legally premarket notification - 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 If you desire specific acries in 1940) 276-0120 . Also, please note the regulation entitled, Colliation of Compunance as (21 t motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on Jour responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
sincerely yours,
Mark A. Melkersen
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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Indications for Use
510(k) Number (if known): TBD_______________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The intended function and use of the Stealth Products Powered Seating System for Power i he intended function and use of the Steath. Free belief to power wheelchair users, by whechenan's is to provide of tilting and reclining the seat and back.
| Prescription Use
AND/OR
| (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | X |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of General. Restorative, and Neurological Devices
16(k) Number K05 0264