TAILWIND

K022704 · Deltaglide · ITI · Aug 27, 2002 · Physical Medicine

Device Facts

• Record ID: K022704
• Device Name: TAILWIND
• Applicant: Deltaglide
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.

Device Story

Tailwind is a light-duty, rear-wheel drive, rigid manual wheelchair with integrated power assist. Input consists of manual force applied to handrims by the user; this action triggers electric motors to provide supplementary power bursts. Steering, braking, and acceleration are controlled via handrims. Device can operate as a standard manual wheelchair when power is off. Used in indoor and light outdoor environments by individuals with physical challenges to improve mobility. Microprocessors manage motor output. Benefits include reduced physical effort for propulsion.

Clinical Evidence

Bench testing only. Testing conducted in accordance with ISO 7176 (Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21) using a 100 kg dummy plus 13.4 kg load.

Technological Characteristics

Materials: Aluminum and steel frame, standard upholstery/cushions. Energy: Rechargeable batteries, DC motors. Control: Microprocessor-based power assist. Form factor: Rigid, rear-wheel drive manual wheelchair. Connectivity: None. Sterilization: N/A.

Indications for Use

Indicated for physically challenged persons requiring enhanced mobility via a power-assisted manual wheelchair.

Regulatory Classification

Identification

A powered wheelchair is a battery-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 2 Power Assist Wheelchair (K001491)

Submission Summary (Full Text)

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AUG 2 7 2002

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Image /page/0/Picture/2 description: The image shows the text "KO22704" and "P. 1/2" on the top line. Below that, the text "CONFIDENTIAL DOCUMENT" is written in bold and all caps. The text appears to be handwritten, and the image is likely a scan of a document.

# 510(k) Summary

#### Submitter's Name and Address

DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 Phone: [phone] Fax: [phone]

#### Contact Person

Jere Perchy Vice President of Operations DeltaGlide, Inc. 3 Industrial Circle Hamden, CT 06517 [phone] extension 102 [e-mail]

Date Prepared June 7, 2002

Name of Device TAILWIND

Classification Name Wheelchair, Powered

Identification of Predicate Device Sunrise Medical Model Quickie 2 Power Assist Wheelchair (K001491)

#### Description of the Device

The TAILWIND power assist wheelchair is a light duty, conventional, rear wheel drive, rigid wheelchair. The TAILWIND wheelchair incorporates power assist components with a typical manual wheelchair. As a motorized wheelchair, it contains motors, drive wheels, and batteries.

The wheelchair is propelled using a mix of human power to manually turn the chair wheels; this action activates the power assist electric motors to provide a short burst of supplementary power.

3 Industrial Circle

Hamden,

ecticut

ı 7

203.230.0301 telephone

203.230.0303 telefax

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### Confidential Document

02/2

#### Intended Use

The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.

#### Comparison to Predicate Device

The device (Tailwind Wheelchair) has similar technological characteristics as the predicated device (Sunrise Medical Model Quickie 2 Power Assist Wheelchair). The device and the predicate are typical manual wheelchair frames; they use aluminum and steel in their frames and components, and standard material and covers for the back upholstery and cushions. Microprocessors are used. Motors employ direct electrical current with rechargeable batteries for an energy source. The operating speeds and maneuverability are equivalent, and the wheelchairs are recommended for indoor and light outdoor use. Standard accessories and components are common.

Both devices use a mix of human and electrical power to propel the wheelchair. Both devices are controlled (steering, braking and accelerating) by means of the handrims. Both devices can be used with the power units turned off. Both devices use conventional wheel locks.

#### Non-Clinical Tests Performed

All applicable tests were voluntarily conducted in accordance with ISO 7176, including Parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 16, and 21. Where applicable a 100 kg dummy (plus 13.4 kg) as specified in ISO 7176 - 11 was used.

#### Summarv

The TAILWIND power assist wheelchair is substantially equivalent to the Sunrise Medical Model Quickie 2 Power Assist Wheelchair in design, function, and features. As shown by the non-clinical testing, any differences between the TAILWIND power assist wheelchair and the predicate device do not raise any questions of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 7 2002

DeltaGlide, Inc. c/o Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06470

Re: K022704

Trade/Device Name: Tailwind Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: July 16, 2002 Received: August 14, 2002

Dear Mr. Steneberg:

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.

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. Heinz Joerg Steneberg

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark A. Mikkelsen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 1: Indications for Use Form

Page 1 of

510(k) Number (if known): KO22704

Device Name: TAILWIND

Indications For Use:

The TAILWIND power assist wheelchair empowers physically challenged persons by providing a means of enhanced mobility.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millkerson

sion of General, Restorative and Neurological Devices

510(k) Number ***_***K022704

(Optional Format 3-10-98)