A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P

K052586 · Taiwan an I Co., Ltd. · IOR · Dec 9, 2005 · Physical Medicine

Device Facts

• Record ID: K052586
• Device Name: A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
• Applicant: Taiwan an I Co., Ltd.
• Product Code: IOR · Physical Medicine
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position. The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.

Device Story

A & I Pediatric and Bariatric Wheelchairs are mechanical mobility aids designed for individuals limited to a sitting position. Pediatric models (RWAL/LT series) serve children; bariatric models (WCDE/WCDS series) serve larger adults. Devices function as manual transport platforms; operated by the user or an attendant. Used in clinical, home, or community settings to facilitate patient mobility. No electronic components, sensors, or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical wheelchair; manual operation. Materials and dimensions vary by model (pediatric vs. bariatric). No energy source, connectivity, or software. Sterilization not applicable.

Indications for Use

Indicated for individuals, primarily children (pediatric models) or larger adults (bariatric models), who are limited to a sitting position and require a mechanical wheelchair for mobility.

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

DEC 9 2005

Taiwan AN I Co., LTD c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127

Re: K052586

Trade/Device Name: A & I Pediatric Wheelchairs Model No. RWAL2006-12 Model No. LT3207-12 Model No. LT3211-12 Model No. LT3207-14 Model No. LT3211-14

> A & I Bariatric Wheelchairs Model No. WCDE2611P Model No. WCDE2811P Model No. WCDE3011P Model No. WCDS2607P Model No. WCDS2807P Model No. WCDS

Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: October 5, 2005 Received: October 5, 2005

Dear Mr. Walls:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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.

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## Page 2 - Kevin Walls, RAC

If your devices 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 n may of belower 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 comply with other requirements of the Act that 1 Dr mas Intact 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 OI K Fat 607); accems (21 (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 devices as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your device and thus, permits your devices 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/industry/support/index.html.

Sincerely yours,

2

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ¿ [COSZS 86

Device Name:

A & I Pediatric Wheelchairs Model No. RWAL2006-12 Model No. LT3207-12 Model No. LT3211-12 Model No. LT3207-14 Model No. LT3211-14

A & I Bariatric Wheelchairs Model No. WCDE2611P Model No. WCDE2811P Model No. WCDE3011P Model No. WCDS2607P Model No. WCDS2807P Model No. WCDS3007P

- Indications for Use: The A&I Pediatric Wheelchairs are intended to provide mobility to persons, primarily children, who may be limited to a sitting position.
The A&I Bariatric Wheelchairs are intended to provide mobility to persons, primarily larger adults, who may be limited to a sitting position.

and and the commended to the first and the comments of

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number_160 6286