KIDS ROCK 3 CHAIR

K111739 · Pride Mobility Products Corp. · IOR · Aug 12, 2011 · Physical Medicine

Device Facts

• Record ID: K111739
• Device Name: KIDS ROCK 3 CHAIR
• Applicant: Pride Mobility Products Corp.
• Product Code: IOR · Physical Medicine
• Decision Date: Aug 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

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.

Device Story

Kids ROCK 3 Chair is a mechanical wheelchair designed for mobility; provides adjustable/customizable seating and positioning for growing users. Features 'Reaction Dynamic Seating System' allowing user movement into flexion or extension while maintaining support. Device is manually propelled; used in various settings by individuals with limited mobility. Output is the physical mobility provided to the user. Benefits include support for growth and postural stability.

Clinical Evidence

No clinical data. Bench testing performed per ANSI/RESNA WC19, ISO 7176-19, ISO 7176-15, ISO 7176-8, ISO 7176-1, ISO 7176-7, ISO 7176-5, and ISO 7176-3.

Technological Characteristics

Mechanical wheelchair; features adjustable seating and manual tilt. Includes Reaction Dynamic Seating System. Tested to ISO 7176 series (stability, dimensions, fatigue, brake efficiency) and ANSI/RESNA WC19 (motor vehicle transport).

Indications for Use

Indicated for persons limited to a seated position requiring mobility assistance. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Pride Mobility Litestream 500E (K042444)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

#### 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).

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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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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

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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 [phone] or [phone] 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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# 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