← Product Code [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR) · K020100

# SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS (K020100)

_Regulatory Insight, Inc. · IOR · Mar 8, 2002 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K020100

## Device Facts

- **Applicant:** Regulatory Insight, Inc.
- **Product Code:** [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR.md)
- **Decision Date:** Mar 8, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3850
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Indications for Use

The SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

## Device Story

Manually operated mechanical wheelchairs; provide mobility to individuals restricted to sitting position. Models include standard, extra-wide, lightweight, and reclinable configurations. Operated by patient or caregiver; used in clinical or home environments. Device provides physical support and transport; no electronic or automated components.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Manually operated mechanical wheelchairs. Materials include steel and aluminum. Models vary by weight (e.g., 29 lbs, 32 lbs) and features (reclinable, extra-wide). No energy source, software, or electronic components.

## 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 MAR

Shanghai Shunlong Physical Therapy Equipment Co., Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K020100

Trade Name: SL 803 Standard Wheelchair

SL 804 Standard Wheelchair

SL 807 Standard Wheelchair

SL 809 Extra Wide Wheelchair

SL 506 Aluminum Light Weight Wheelchair - 29 Ibs

SL 501 Light Weight Wheelchair - 32 lbs

SL 805 Standard Wheelchair

SL 801 Reclinable Wheelchair

Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: I Product Code: IOR Dated: January 10, 2002

Received: January 11, 2002

Dear Mr. Walls:

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.

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## Page 2 - Mr. Kevin Walls

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.

- 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 Division of Small Manufacturers, 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 vours.

Sincerely yours,

R. Mark N. Millerson

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

2

Enclosure

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510(k) Number (if known):

Device Name:

SL 803 Standard Wheelchair SL 804 Standard Wheelchair SL 807 Standard Wheelchair SL 809 Extra Wide Wheelchair SL 506 Alum. Light Weight Wheelchair-29lbs SL 501 Light Weight Wheelchair-32lbs SL 805 Standard Wheelchair SL 801 Reclinable Wheelchair

Indications for Use: The SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number

2

Prescription Use **__**
(Per 21 CFR 801.109)

OR

Over the Counter Use *X*

for

Mark n Mellum

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

510(k) Number .

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K020100](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K020100)

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