(42 days)
Not Found
No
The description details a standard mechanical wheelchair with no mention of AI or ML capabilities.
No
The device is a mechanical wheelchair, which is a mobility aid. While it enhances a user's ability to move, it does not provide any direct therapeutic benefits such as treating a medical condition or restoring function in a rehabilitative manner.
No
The device is described as a mechanical wheelchair designed to provide mobility, not to perform any diagnostic functions. Its intended use and description refer to physical assistance for movement, and it undergoes tests for stability, braking, and durability, not for disease detection or diagnosis.
No
The device description clearly outlines a physical mechanical wheelchair with components like a seat frame, backrest, armrests, legrests, and wheels. It also details material properties and physical performance testing.
Based on the provided information, the Litestream 500E is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited mobility, which is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is a mechanical wheelchair, designed for physical support and movement. It does not interact with biological samples or perform any diagnostic analysis.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, analyzing, or interpreting biological samples (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies listed are related to the physical characteristics and safety of the wheelchair (stability, brakes, dimensions, etc.), not diagnostic accuracy or performance.
In summary, the Litestream 500E is a medical device designed for mobility assistance, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The intended use of the Litestream 500E is to provide mobility to persons limited to a seated position that are capable of operating a mechanical wheelchair.
The Litestream 500E mechanical wheelchair enhances the mobility of users whom are partially or fully non-ambulatory.
Product codes
IOR
Device Description
The Litestream 500E mechanical wheelchair is lightweight and designed to provide mobility based on the user's capabilities and needs, with propulsion by the user or an attendant. To better adapt to individual needs, the Litestream 500E is available in various seat sizes, and features component adjustments to enhance fitting and performance.
With hand-rim drive wheels in the rear, and pivoting front casters, the Litestream 500E steers according to typical mechanical wheelchairs, and features common wheelchair components, including a seat frame, backrest, armrests, legrests, and wheel locks.
The Litestream 500E performs well indoors, and maintains its performance on firm, smooth, surfaces, as well as those that are free of steep angles and obstacles. For durability and less weight, the frame material is aluminum, with a seat and backrest upholstery fabric that meets the California CAL177 Standard for flammability. The Litestream 500E Owner's Manual contains descriptions and specifications toward meaningful use, operation, and care of the wheelchair.
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
Non-Clinical Testing:
ANSI/RESNA WC/01 Determination of Static Stability Testing
ANSI/RESNA WC/03 Test Methods and Requirements for the Effectiveness of Brakes
ANSI/RESNA WC/05 Determination of Overall Dimensions and Turning Space
ANSI/RESNA WC/08 Static Impact, Fatique, and Strength Tests
ANSI/RESNA WC/11 Test Dummies
ANSI/RESNA WC/13 Coefficient of Friction
ANSI/RESNA WC/15 Documentation and Labeling
ANSI/RESNA WC/93 Maximum Overall Dimensions
Cal 117 - Flammability Testing
Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 - 2004
Mr. Thomas Schappert Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pennsylvania 18643
Re: K042444
Trade/Device Name: Litestream 500E Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 13, 2004 Received: September 9, 2004
Dear Mr. Schappert:
This letter corrects our substantially equivalent letter of October 21, 2004 regarding the incorrect spelling of the Trade/Device Name as Lifestream. The correct spelling of the device is listed above.
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 (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 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
1
Page 2 - Mr. Thomas Schappert
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.
This letter will allow you to continue 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 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,
Mark N. Melkerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Exhibit 3
Indications for Use
510(k) Number (if known): K
Device Name: Litestream 500E Mechanical Wheelchair
Indications for Use: The intended use of the Litestream 500E is to provide mobility to persons limited to a seated position that are capable of operating a mechanical wheelchair.
The Litestream 500E mechanical wheelchair enhances the mobility of users whom are partially or fully non-ambulatory.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millham
Division Sign-Off)
Division of General, Restorative. and Neurological Devices
KO42444
510(k) Number_
Page 1 of 1
N
3
Image /page/3/Picture/1 description: The image shows the logo for Pride Mobility Products Corporation. The word "Pride" is written in large, bold, black letters. Below the word "Pride" is the text "Mobility Products Corporation" in a smaller font. The logo has a distressed or grunge effect, with splatters and rough edges around the text.
OCT 2 1 2004
Exhibit 1
510 (K) Summary Pride Mobility Products Corporation Litestream 500E
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Thomas Schappert
Date Prepared:
August 13, 2004
Name of Device and Proprietary Name: Litestream 500E / Pride Mobility
Common or Usual Name:
Manual Wheelchair
Classification Name:
Wheelchair, Mechanical
Product Code:
IOR
Comparison to Predicate Devices:
The Litestream 500E Mechanical Wheelchair is substantially equivalent to the Sunrise Medical Quickie (K850536)
Device Description:
The Litestream 500E mechanical wheelchair is lightweight and designed to provide mobility based on the user's capabilities and needs, with propulsion by the user or an attendant. To better adapt to individual needs, the Litestream 500E is available in various seat sizes, and features component adjustments to enhance fitting and performance.
4
Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corporation. The word "Pride" is written in a bold, stylized font, with the letters overlapping each other. Below the word "Pride" is the text "Mobility Products Corporation" in a smaller font. The logo is surrounded by a grainy, textured background.
With hand-rim drive wheels in the rear, and pivoting front casters, the Litestream 500E steers according to typical mechanical wheelchairs, and features common wheelchair components, including a seat frame, backrest, armrests, legrests, and wheel locks.
The Litestream 500E performs well indoors, and maintains its performance on firm, smooth, surfaces, as well as those that are free of steep angles and obstacles. For durability and less weight, the frame material is aluminum, with a seat and backrest upholstery fabric that meets the California CAL177 Standard for flammability. The Litestream 500E Owner's Manual contains descriptions and specifications toward meaningful use, operation, and care of the wheelchair.
Intended Use:
The intended use of the Litestream 500E is to provide mobility to persons limited to a seated position that are capable of operating a mechanical wheelchair.
The Litestream 500E manual wheelchair enhances the mobility of users who are partially or fully non-ambulatory.
Non-Clinical Testing:
ANSI/RESNA WC/01 Determination of Static Stability Testing ANSI/RESNA WC/03 Test Methods and Requirements for the Effectiveness of Brakes ANSI/RESNA WC/05 Determination of Overall Dimensions and Turning Space ANSI/RESNA WC/08 Static Impact, Fatique, and Strength Tests ANSI/RESNA WC/11 Test Dummies ANSI/RESNA WC/13 Coefficient of Friction ANSI/RESNA WC/15 Documentation and Labeling ANSI/RESNA WC/93 Maximum Overall Dimensions Cal 117 - Flammability Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Litestream 500E has the same intended use and similar technological characteristics as the Quickie. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the 500E mechanical wheelchair is substantially equivalent to the predicate device.