SPECTRUM LIBRE WHEELCHAIR

K993640 · Freedom Designs, Inc. · IOR · Nov 16, 1999 · Physical Medicine

Device Facts

• Record ID: K993640
• Device Name: SPECTRUM LIBRE WHEELCHAIR
• Applicant: Freedom Designs, Inc.
• Product Code: IOR · Physical Medicine
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Folding Mobility Wheelchair This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Device Story

Spectrum Libre is a folding mobility wheelchair serving as a transport base for pediatric clients. Device provides mobility support; does not diagnose, treat, prevent, cure, or mitigate disease. Operated by caregivers or patients in clinical or home settings. Output is physical mobility assistance. Benefits include improved patient transport and positioning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Folding mobility wheelchair; manual operation; pediatric form factor. No electronic components, software, or energy sources.

Indications for Use

Indicated for pediatric clients requiring a transport base wheelchair.

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 1 6 1999

Ms. Ginny S. Maloco President Freedom Designs, Inc. 2241 Madera Road 93065 Simi Valley, California

K993640 Re: Spectrum Libre Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: October 26, 1999 Received: October 28, 1999

Dear Ms. Maloco:

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, 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 (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. ಗಿ 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 requlation (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 requlations.

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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 regulation (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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STO(K) NUMBER (II: KNOWN) :

DEVICE NAME: Spectrum Libre INDICATIONS FOR USE:

Folding Mobility Wheelchair

This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Ser 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format 1/2-96)

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