IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)

K964977 · Interactive Living Systems, Inc. · LFF · Aug 31, 1998 · Physical Medicine

Device Facts

• Record ID: K964977
• Device Name: IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
• Applicant: Interactive Living Systems, Inc.
• Product Code: LFF · Physical Medicine
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3920
• Device Class: Class 1

Indications for Use

IVOC—Integrated Voice Operated Control system for electric wheelchairs, allows the occupant to control movement of their chair by using voice commands. Controllers. The user’s wheelchair must have one of the following controllers: A. Invacare MK IV controller. B. Everest and Jennings Z-51 or Z-61 controller. C. Quickie P100, P200, or P300 controller. D. Dynamic Controls Ltd. DX-Power controller. Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds. Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.

Device Story

IVOC is a voice-operated control system for electric wheelchairs; enables hands-free navigation for users with mobility impairments. Input: user voice commands/sounds. Processing: system interprets vocal inputs to generate control signals for wheelchair motor controllers. Output: movement commands to compatible wheelchair controllers (Invacare MK IV, E&J Z-51/Z-61, Quickie P100/P200/P300, Dynamic DX-Power). Used in home or community settings by the wheelchair occupant. Safety feature: requires user to maintain ability to operate a manual emergency stop switch. Benefits: provides increased independence and mobility for users unable to operate standard manual wheelchair joysticks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Voice-operated control interface; integrates with existing electric wheelchair motor controllers via electronic signal interface. Requires specific compatible controller models. Operates as an add-on module to existing wheelchair electronics.

Indications for Use

Indicated for individuals requiring voice-controlled operation of electric wheelchairs. Users must possess consistent vocal capability to reproduce commands/sounds and the physical ability to activate a manual emergency stop switch. Compatible with specific Invacare, Everest and Jennings, Quickie, and Dynamic Controls Ltd. wheelchair controllers.

Regulatory Classification

Identification

A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 31 1998

Mr. Ken Hollenbeck
President
Interactive Living Systems, Inc.
14901 East Hampden Avenue, Suite 310
Aurora, Colorado 80014

Re: K964977
Integrated Voice Operated Control Unit (IVOC-1)
for Powered Wheelchairs
Regulatory Class: II
Product Code: LFF
Dated: July 31, 1998
Received: August 6, 1998

Dear Mr. Hollenbeck:

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 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 (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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Ken Hollenbeck

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,


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

Enclosure

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510(K) Number (if known): K964977

Device Name: IVOC

Indications For Use: IVOC—Integrated Voice Operated Control system for electric wheelchairs, allows the occupant to control movement of their chair by using voice commands.

Controllers. The user’s wheelchair must have one of the following controllers:

A. Invacare MK IV controller.
B. Everest and Jennings Z-51 or Z-61 controller.
C. Quickie P100, P200, or P300 controller.
D. Dynamic Controls Ltd. DX-Power controller.

Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds.

Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.

(Please do not write below this line—continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use (21 CFR 801.109)

OR

Over-the-Counter Use ☑ (Optional Format 1-2-96)