← Product Code [IOR](/productcode/IOR) · K013761

# MEDLINE EXCEL RECLINCER WHEELCHAIR (K013761)

_Medline Industries, Inc. · IOR · Dec 6, 2001 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K013761

## Device Facts

- **Applicant:** Medline Industries, Inc.
- **Product Code:** [IOR](/productcode/IOR.md)
- **Decision Date:** Dec 6, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3850
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Indications for Use

The intended use of the Medline Excel Recliner Wheelchair is to provide mobility to persons limited to a sitting position but unable to sit in an upright position for long periods of time.

## Device Story

Medline Excel Recliner Wheelchair is a mechanical mobility aid designed for individuals unable to maintain an upright sitting position. Device provides support and mobility for patients in clinical or home settings. Operated by patient or caregiver. Reclining mechanism allows adjustment of seat angle to accommodate user comfort and postural needs. Device functions as a standard mechanical wheelchair with manual adjustment features. No electronic components, software, or automated processing involved.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Mechanical wheelchair; manual operation; reclining seat mechanism; standard materials for wheelchair construction (e.g., metal frame, upholstery). No energy source, connectivity, or software.

## Regulatory 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.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Medline Industries, Inc. Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs One Medline Place Mundelein, Illinois 60060-4486

Re: K013761

Trade Name: Medline Excel Recliner Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: November 9, 2001 Received: November 13, 2001

Dear Ms. Haferkamp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Andrea Haferkamp

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to began inding of substantial equivalence of your device to a legally premarket notification: "The Price is 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 II you desire specific advisor you in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Comphance at (301) 597-1057. The case Compliance at (301) 594-4639. 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 Ourler general mionmation on your international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Marls M. Milherson

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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Section 2.0 Intended Use

K013761

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): Device Name: Medline Excel Recliner Wheelchair

Indications for Use:

The intended use of the Medline Excel Recliner Wheelchair is to provide mobility to persons limited to a sitting position but unable to sit in an upright position for long periods of time.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use - - -

(Optional Format 12-96)

R. Mad. A. Millers

510(k) Number

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**Source:** [https://fda-staging.innolitics.com/device/K013761](https://fda-staging.innolitics.com/device/K013761)

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