COMFY HIGH RISER WHEELCHAIR

K022617 · Lenjoy Medical Engineering, Inc. · IOR · Sep 13, 2002 · Physical Medicine

Device Facts

• Record ID: K022617
• Device Name: COMFY HIGH RISER WHEELCHAIR
• Applicant: Lenjoy Medical Engineering, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Sep 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

THE COMFY HIGH-RISER WHEELCHAIR MODEL 1 IS DESIGNED TO PROVIDE THE USER A CHANGE IN SITTING POSITION FROM A SEATED TO A FULLY EXTENDED ELEVATION.

Device Story

Comfy High-Riser Model 1 is a manual wheelchair; provides user-controlled transition from seated position to fully extended elevation. Operated by user or caregiver; intended for mobility and postural adjustment. Mechanical design facilitates elevation change to assist with daily activities or positioning. Benefits include improved accessibility and comfort through adjustable seating posture.

Technological Characteristics

Manual wheelchair; mechanical elevation mechanism; standard materials for wheelchair construction.

Indications for Use

Indicated for users requiring a change in sitting position from a seated to a fully extended elevation.

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

• Standard Manual Wheelchair

Submission Summary (Full Text)

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SEP 1 3 2002

K022617

## 510K Summary

510K Document Number: (Awaiting FDA Approval)

| Date Prepared: | May 28, 2002 |
|------------------------|-------------------------------------------------------------------------------|
| Applicant: | Lenjoy Medical Engineering, Inc.<br>13112 Crenshaw Blvd.<br>Gardena, CA 90249 |
| Telephone Number: | 310-353-2481<br>800-582-5332 |
| Fax Number: | 310-353-2484 |
| E-Mail Address: | [e-mail] |
| Contact Person: | Leah Rotter / President |
| Device Trade Name: | Comfy High-Riser Model 1 Manual Wheelchair |
| Device Common Name: | Comfy High-Riser Wheelchair |
| Classification Parrel: | Physical Medicine |
| Classification Name: | Manual Wheelchair |
| Product Code: | 89010R |
| Device Class: | II |

## Legally Marketed Devices to which we Claim Substantial Equivalence

Standard Manual Wheelchair (See 510K Designator for predicant devices)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 3 2002

Lenjoy Medical Engineering, Inc. Leah Rotter President 13721 Gramercy Place Gardena, California 90249-2469

Re: K022617

Trade/Device Name: Comfy High Riser Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: July 23, 2002 Received: August 7, 2002

Dear Mr. Rotter:

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. Leah Rotter

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" (21 CFR 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,

Mark A. Millbern

for Colin M. Wittwer, Ph.D., M.D.

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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S10(k) Number (if known): __ K022617 Device Name: COMEY Hilott, Rise UHEE CHAIR Indications For Use:

INTENDED USE OF THE COMFY Hibt THE WHEEL CHAIR MODEL I is desiGNED THE USER A CHANGE IN SITTING A SCENDED THE Fully EXTENDED ELEVATION.

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

for-Muriel N-Millken
(Optiona

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number