ESCAPE CONTROL MODULE

K021995 · Specialty Drives Technologies, Inc. · ITI · Aug 1, 2002 · Physical Medicine

Device Facts

• Record ID: K021995
• Device Name: ESCAPE CONTROL MODULE
• Applicant: Specialty Drives Technologies, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Indications for Use

The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.

Device Story

The Escape Control Module is a non-contact, proportional head-movement controller for powered wheelchairs. It translates user head movements into directional and speed commands for the wheelchair drive system. Designed for individuals with limited mobility who are restricted to a seated position, the device allows for hands-free operation. It functions as an interface between the user's physical movement and the wheelchair's motor controller, enabling navigation and mobility. The device is intended for use by patients in various settings where powered wheelchair use is required.

Technological Characteristics

Non-contact, proportional head-movement sensing interface for powered wheelchairs. Designed as an accessory to existing powered wheelchair control units.

Indications for Use

Indicated for persons restricted to a seated position requiring mobility assistance via powered wheelchair operation.

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.

Predicate Devices

• Dynamic Systems PHC-2
• Dynamic Systems PHC-3
• Adaptive Switch Laboratories Inc.'s ASL Head Array
• Invacare's Sip and Puff head array
• Invacare's Remote Joystick

Submission Summary (Full Text)

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# AUG 01 2002

K021995

#### 510(k) Summary

### Specialty Drive Technologies, Inc.'s Escape Control Module

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: [phone] Fax: [phone]

Contact Person: Scott Kersey

Date Prepared:June 17, 2002

#### Name of Device and Name/Address Of Sponsor

Escape Control Module Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: [phone] 586-0917 Fax:

#### Common or Usual Name

Escape Control Module

#### Classification Name

Power Wheelchair Control Unit

#### Predicate Devices

The Escape Control Module is substantially equivalent to Dynamic Systems PHC-2 and PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array and Invacare's Remote Joystick.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

Specialty Drives Technologies, Inc. Scott Kersey 509 Pleasant Hill Church Road Winder. Georgia 30680

Re: K021995

Trade Name: Escape Control Module Regulation Number: 890.3860 Regulation Name: Wheelchair, powered (accessory) Regulatory Class: II Product Code: ITI Dated: June 17, 2002 Received: June 18, 2002

Dear Mr. Kersey:

We have reviewed your Section 510(k) premarket 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) 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. Scott Kersey

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Sincerely yours,

Mark H. Milkman

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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# INDICATIONS FOR USE STATEMENT

510(k) Number: _ KO21995

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name:

Indications for Use: The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use <span style="text-decoration: underline;">✓</span><br>(Optional Format 1-2-96) |
|------------------------------------------|----|-----------------------------------------------------------------------------------------------------|
|------------------------------------------|----|-----------------------------------------------------------------------------------------------------|

*for*

| (Division Sign-Off) | (Division Sign-Off) |
|--------------------------------------------------------------|-----------------------------------------|
| Division of General, Restorative<br>and Neurological Devices | Division of General Restorative Devices |
| 510(k) Number | 510(k) Number |
| K021995 | |

Mark N. Melleur