MILLENIUM II

K081665 · Next Mobility, LLC · IOR · Jun 27, 2008 · Physical Medicine

Device Facts

• Record ID: K081665
• Device Name: MILLENIUM II
• Applicant: Next Mobility, LLC
• Product Code: IOR · Physical Medicine
• Decision Date: Jun 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Indications for Use

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

Device Story

Millenium II is a manual mechanical wheelchair designed to provide mobility to users with limited ambulatory function. The device is operated by the user via manual propulsion. It features adjustable seat widths and an axle configuration to accommodate a travel wheel. The device utilizes push-to-lock wheel locks. It is intended for use in various environments where manual wheelchair mobility is required. The device provides a means of independent movement for the patient, improving accessibility and daily function.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 7176 (Parts 1, 5, 15, 16, and 93) using a 112.4 kg test dummy (100 kg dummy plus 12.4 kg) per ISO 7176-11.

Technological Characteristics

Mechanical manual wheelchair. Features include adjustable seat widths, axle for travel wheel, and push-to-lock wheel locks. Testing performed per ISO 7176 standards (Parts 1, 5, 15, 16, 93).

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

• Invacare Tracer (K935398)

Submission Summary (Full Text)

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KO 81665

JUN 2 7 2008

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

## Manufacturer Name and Address

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

## Contact Person / Requiatory Correspondent

Joseph Azarv Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Phone: [phone] Fax: [phone] Email: [e-mail] or [e-mail]

## Date Prepared

March 14, 2008 [Revised on June 26, 2008]

Name of Device MILLENIUM II

## Classification Name

Wheelchair, Mechanical

### Identification of Predicate Device

Invacare Tracer K935398

## Description of the Device Intended Use

The Millenium II wheelchairs are intended to provide mobility to persons limited to a seated position that are capable of operating a manual wheelchair.

#### Comparison to Predicate Device

This device has a similar intended use and technological characteristics as the predicate device. The main differences are the Millenium offers additional seat widths, axle to accommodate a travel wheel (the travel wheel is not part of this submission), and the wheel locks are push to lock only. The device and predicate device are both mechanical wheelchairs.

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## Non-Clinical Tests Performed

All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 5, 15, 16, and 93. Where applicable a 100 kg dummy (plus 12.4 kg) as specified in ISO 7176 - 11 was used.

Testing to parts 3 and 8 will be completed prior to product launch and commercialization.

## Summary

In conclusion we believe the subject device is a low risk device that complies with internationally recognized standards and substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NEXT Mobility, LLC % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, NC 27709

Re: K081665 Trade/Device Name: Millenium II Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 12, 2008 Received: June 13, 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 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.

JUN 2 7 2008

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.

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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 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 M. Millman

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: Millenium II

Indications For Use:

The Millenium wheelchairs are intended to provide mobility 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-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sigui-Off) Page 1 of 1 Division of General, Restorative, and Neurological Devices

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510(k) Number