RTM AND OVAL

K080880 · Next Mobility, LLC · IOR · Apr 9, 2008 · Physical Medicine

Device Facts

• Record ID: K080880
• Device Name: RTM AND OVAL
• Applicant: Next Mobility, LLC
• Product Code: IOR · Physical Medicine
• Decision Date: Apr 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

Device Story

The RTm and Oval are manual wheelchairs designed to provide mobility for individuals with limited seated mobility. The devices are operated by the user. They function as standard mechanical mobility aids. No electronic, software, or algorithmic components are involved in their operation. The devices are intended for use in various environments where manual wheelchair navigation is appropriate.

Clinical Evidence

Bench testing only. The device underwent testing per ISO 7176-1 (Static Stability), ISO 7176-5 (Dimensions, Mass, Turning Space), ISO 7176-15 (Information Disclosure), ISO 7176-16 (Resistance to Ignition), and ANSI/RESNA WC Volume 1-1998 Section 93 (Maximum Dimensions). Testing utilized a 100 kg dummy plus 12.4 kg ballast per ISO 7176-11.

Technological Characteristics

Mechanical manual wheelchair. Tested to ISO 7176-1, 7176-5, 7176-15, 7176-16, and ANSI/RESNA WC Volume 1-1998 Section 93 standards. No electronic components, software, or energy sources.

Indications for Use

Indicated for individuals limited to a seated position who possess the physical capability to operate a manual wheelchair.

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

• Sunrise Medical Model Quickie GT Manual Wheelchair (K850536)

Submission Summary (Full Text)

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Confidential Document 510(k) Summary (as required by 21 CFR 807.92(c))

### Manufacturer Name and Address

APR - 9 2008

NEXT Mobility LLC 7444 Haggerty Road Canton, MI 48187 Phone [phone] Fax [phone]

# Contact Person

Joseph Azary Regulatory Consultant 543 Long Hill Avenue Shelton, CT 06484 Phone [phone] Fax [phone]

# Prepared By:

Chris White Joseph Azary

### Date Prepared

Revised March 25, 2008

# Name of Device

- 1) RTM 2) Oval
### Classification Name

Wheelchair, Mechanical

# Identification of Predicate Device

Sunrise Medical Model Quickie GT Manual Wheelchair (K850536)

# Description of the Device Intended Use

The RTm and Oval wheelchairs are intended to provide mobility to persons limited to a seated position that are :apable of operating a manual wheelchair.

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#### Comparison to Predicate Device

This device has a similar intended use and technological charaçteristics as the predicate device. The device and the predicate device are both mechanical wheelchairs. Compari ons demonstrate substantial equivalence.

#### Non-Clinical Tests Performed

All applicable tests were voluntarily conducted in accordance with the following standards:

ISO 7176-5 Determination of Overall Dimensions, Mass, and Turning Space

ISO 7176-15 Requirements for inf >rmation disclosure, documentation, and labeling

ISO 7176-16 Resistance to ignition of upholstered parts requirements and test methods.

ISO 7176-1 Determination of Stat c Stability

ANSI/RESNA WC Volume 1-1998 Section 93 Maximum Overall Dimensions

Where applicable a 100 kg dumm / (plus 12.4 kg) as specified in ISO 7176 -11 was used.

### Technological Characteristics

The device has been subjected to and successfully passed testing to voluntary standards.

### Summary

We believe the subject devices ar : substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR - 9 2008

NEXT Mobility, LLC c/o Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle Park, NC 27709

Re: K080880 Trade/Device Name: RTm and Oval Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 27, 2008 Received: March 31, 2008

Dear Mr. Rongero:

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 area waren in 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 r ou may, dierelove, maines 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 If your device is elassined tootrols. Existing major regulations affecting your device can may be subject to back academans, 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 r lease of advised that I Dr Fristantly or our device complies with other requirements of the Act that I DT has Intade a actives and regulations administered by other Federal agencies. You must or any i catal battator and a weeks including, but not limited to: registration and listing (21 Configity with an the Fice of requirements, on the source requirements as set Cr K I at 607), nooning (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeff D. Rongero

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson 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):

Device Name: 1) RTm 2) Oval

Indications For Use:

The RTm and Oval wheelchairs are intended to provide r lobility to persons limited to a seated position that are capable of operating a manual wheelchair.

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-C )NTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office ( f Device Evaluation (ODE)

Wilke Ogl. Gormxn

(Division (Division of General, Restorat Division rological Devices

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510(k) Number K080880