TACAHE PC1350 POWER WHEELCHAIR

K080373 · Dalton Medical Corp. · ITI · Apr 14, 2008 · Physical Medicine

Device Facts

• Record ID: K080373
• Device Name: TACAHE PC1350 POWER WHEELCHAIR
• Applicant: Dalton Medical Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Apr 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Tacahe PC1350 is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Story

Tacahe PC1350 is a powered wheelchair designed to provide mobility for individuals with limited physical ability to walk. Device operates via user-controlled interface allowing navigation in indoor and outdoor environments. Intended for use by patients who are capable of operating the controls. Provides independent mobility; improves quality of life by facilitating movement for seated users.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered wheelchair; Class II; Product Code ITI; 21 CFR 890.3860. Standard powered mobility platform.

Indications for Use

Indicated for individuals with mobility limitations who are restricted to a seated position and possess the physical and cognitive capability to operate a powered wheelchair.

Regulatory Classification

Identification

A powered wheelchair is a battery-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

## APR 1 4 2008

Dalton Medical Corp. c/o Mr. Will Ridgway 1103 Venture Court Carrollton, TX 75006

Re: K080373 Trade/Device Name: Tacahe PC1350 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 3, 2008 Received: April 3, 2008

Dear Mr. Ridgway:

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, 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 - Mr. Will Ridgway

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

Mark N. Melkerson 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):

Device Name: Tacahe PC1350

Indications For Use:

:

...

The intended use of the Tacahe PC1350 is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR :

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THI:S LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Off ce of Device Evaluation (ODE)

Nil R.E.Q. for mxm
Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

K080373 510(k) Number_

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