HERO 1, MODEL LY-ESB220

K031621 · Comfort Orthopedic Co., Ltd. · IPL · Jan 22, 2004 · Physical Medicine

Device Facts

• Record ID: K031621
• Device Name: HERO 1, MODEL LY-ESB220
• Applicant: Comfort Orthopedic Co., Ltd.
• Product Code: IPL · Physical Medicine
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

Device Story

Comfort Standing Wheelchair (Hero 1, Model LY-ESB220) is a motorized mobility device; enables transition between sitting and standing positions; provides seat and backrest recline and lift functions; facilitates indoor and outdoor mobility. Operated by the user; intended for individuals unable to stand independently due to conditions like spinal cord injury or cerebral palsy. Device provides postural support and mobility assistance; improves patient independence and physiological benefits associated with standing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized standing wheelchair; provides sitting, standing, and reclining positions; seat and backrest lift mechanism; indoor/outdoor mobility capability.

Indications for Use

Indicated for individuals requiring a standing wheelchair who cannot stand independently, including those with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, or rheumatism.

Regulatory Classification

Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2004

Mr. Eric H. C. Lee Official Correspondent Comfort Orthopedic Company, LTD. 120 Nan Shiang Tsuen Shoei Shang Shiang Chia-Yi, Taiwan

Re: K031621

Trade/Device Name: Comfort Standing Wheelchair - Hero 1. Model LY-ESB220 Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Il Product Codes: IPL Dated: December 26, 2003 Received: December 30, 2003

Dear Mr. Lee:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 docs 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. Eric H. C. Lec

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Mulkerson

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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## 510 (K) NUMBER ( IF KNOWN ): TBA

DEVICE NAME: COMFORT Standing Wheelchair, HERO 1 LY-ESB220

Intended Use:

The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

Target Population:

For all individuals who need a standing Wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

for Mark N Milliken

K03162

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

Concurrence of CDRH, office of Device Evaluation (ODE )

Prescription Use

OR

Over-The-Counter-Use

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )