(52 days)
Not Found
No
The document describes a mechanical wheelchair with adjustable seating and a dynamic seating system, with no mention of AI or ML terms or functionalities.
No
The device is a mechanical wheelchair designed for mobility, not for treating any specific medical condition or disease.
No
The device is described as a mechanical wheelchair intended for mobility, not for diagnosing medical conditions. The performance studies listed are related to safety and physical properties of the chair, not diagnostic accuracy.
No
The device description explicitly states it is a "Mechanical Wheelchair" and details physical components and testing related to mechanical performance and safety standards for wheelchairs. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons limited to a seated position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The device is described as a "Mechanical Wheelchair" with features for adjustable seating and positioning. This aligns with a mobility aid, not an IVD.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing diagnostic information
The information provided clearly describes a medical device designed for mobility and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
Product codes
IOR
Device Description
The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.
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)
Non-Clinical Testing:
ANSI/RESNA WC19 Wheelchairs Used as Seats in Motor Vehicles
ISO 7176-19 Wheeled Mobility Devices for Use in Motor Vehicles
ISO 7176-15 Requirements for information disclosure, documentation, and labeling
ISO 7176-8 Requirements and test methods for static, impact, and fatigue strengths
ISO 7176-1 Determination of static stability
ISO 7176-7 Measurement of seating and wheel dimensions
ISO 7176-5 Determination of overall dimensions, mass, and turning space
ISO 7176-3 Determination of efficiency of brake
Manually propelled wheelchairs
Technical Aids for Disabled Persons
Fabric and Foam Testing
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).
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Image /page/0/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with the "i" dotted with a registered trademark symbol. Below the word "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font.
KIII739
AUG 1 2 2011
Exhibit 1 510(k) Summary Pride Mobility Products Corporation Kids ROCK 3 Chair
Submitter's Name & Address:
Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, Pa. 18643 Phone: (570) 655-5574 Facsimile: (570) 655-2990
Contact Person:
Kimberly Blake Assistant Manager, Regulatory
Date Prepared:
6/17/2011
Name of Device and Proprietary Name:
Kids ROCK 3 Chair / Pride Mobility Products Corporation
Common or Usual Name:
Mechanical Wheelchair
Classification Name:
Physical Medicine / Mechanical Wheelchair
Product Code:
IOR
Comparison to Predicate Devices:
The Kids ROCK 3 Chair is substantially equivalent to the Pride Mobility Litestream 500E (K042444) when comparing performance, maneuverability, stability, and structure. The performance characteristics are similar to achieve the same intended use functions that enable the device to maintain optimum stability without hindering performance.
The major differences between the Kids ROCK 3 Chair and the Litestream 500E (K042444) are in the seating. The Kids ROCK 3 Chair seating is adjustable to allow for growth as the user moves through various stages of life and offers a manual tilting feature.
Please refer to Exhibit 4 for specific product descriptions and comparison of the Kids ROCK 3 Chair to the cleared Litestream 500E (K042444).
ﻨﺴﻴﺔ ﻧ
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Image /page/1/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, slanted font, with a registered trademark symbol next to the "e". Below the word "Pride" is the text "Mobility Products Corp."
Device Description:
The Kids ROCK 3 Chair is a Mechanical Wheelchair that offers adjustable and customizable seating and positioning to meet the needs of a growing client. The Reaction Dynamic Seating System allows a user the freedom to move into flexion or extension in the chair while maintaining proper positioning and support.
Intended Use:
The intended use of the Pride Mobility Products Corporation Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
Non-Clinical Testing:
ANSI/RESNA WC19 Wheelchairs Used as Seats in Motor Vehicles ISO 7176-19 Wheeled Mobility Devices for Use in Motor Vehicles ISO 7176-15 Requirements for information disclosure, documentation, and labeling ISO 7176-8 Requirements and test methods for static, impact, and fatigue strengths ISO 7176-1 Determination of static stability ISO 7176-7 Measurement of seating and wheel dimensions ISO 7176-5 Determination of overall dimensions, mass, and turning space ISO 7176-3 Determination of efficiency of brake Manually propelled wheelchairs Technical Aids for Disabled Persons Fabric and Foam Testing
Discussion of Clinical Testing Performed:
N/A
Conclusions:
The Kids ROCK 3 Chair has the same intended use and similar technological characteristics as the Litestream 500E (K042444). 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 Kids ROCK 3 Chair is substantially equivalent to the Litestream 500E (K042444).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is positioned around the perimeter of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002
Pride Mobility Products Corporation % Ms. Kimberly Blake Assistant Manager, Regulatory 182 Susquehanna Avenue Exeter, PA 18643
Re: K111739
Trade/Device Name: Kids ROCK 3 Chair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 11, 2011 Received: July 14, 2011
AUG 12 2011
Dear Ms. Blake:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good nianufacturing practice requirements as set
3
Page 2 - Ms. Kimberly Blake
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millhiser
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Pride Mobility Products Corp. The word "Pride" is written in a bold, sans-serif font, with a registered trademark symbol to the right of the "e". Below "Pride" is the text "Mobility Products Corp." in a smaller, sans-serif font.
Exhibit 3
Indications for Use
510(k) Number (if known): K
Kids ROCK 3 Chair Device Name:
Indications for Use: The intended use of the Kids ROCK 3 Chair is to provide mobility to persons limited to a seated position.
Prescription Use × (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)
Thurman L. Gray
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111739