WHEELCHAIR (MANUAL, NOT ELECTRICAL)

K992884 · Foshan Machinery & Equipment Import & Export Co. · IOR · Nov 2, 1999 · Physical Medicine

Device Facts

• Record ID: K992884
• Device Name: WHEELCHAIR (MANUAL, NOT ELECTRICAL)
• Applicant: Foshan Machinery & Equipment Import & Export Co.
• Product Code: IOR · Physical Medicine
• Decision Date: Nov 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1

Intended Use

In order to transport patient(s) and/or disable people This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.

Device Story

Manual, non-electrical wheelchair; designed for patient transport. Operated by a caregiver (nurse, assistant, staff, or family member) rather than the patient. Used on even surfaces (concrete, pavement, indoor floors) to ensure safety and effectiveness. Provides mobility assistance for patients or disabled individuals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, non-electrical wheelchair. Form factor is a standard manual chair. No energy source, software, or complex electronics.

Indications for Use

Indicated for the transport of patients or disabled individuals. Recommended for operation by a nurse, assistant, nursing home staff, or family member on even surfaces such as concrete, pavement, or indoor floors.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 1999

Mr. Don W. Kang Manager JTS Price Corporation 2414 Second Street Fort Lee, New Jersey 07024

K992884 Re: Wheel Chair (manual, not electrical) Trade Name: Requlatory Class: I Product Code: IOR Dated: Undated August 23, 1999 Received:

Dear Mr. Kang:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. ਸੀ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Don W. Kang

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colia M. Witton, Ph.D., M.D.

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

Enclosure

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K992884 510(k) Number (if known):

WHEEL CHAIR(MANUAL,NOT ELECTRICAL) Device Name:

Indications For Use:

In order to transport patient(s) and/or disable people

This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices 510(k) Number +

. rescription Use (Per 21 CFR 801.109)

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**Over-The-Counter Use**

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