ACTIVX

K984367 · Adorno Rogers Technology · IOR · Jan 28, 1999 · Physical Medicine

Device Facts

• Record ID: K984367
• Device Name: ACTIVX
• Applicant: Adorno Rogers Technology
• Product Code: IOR · Physical Medicine
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.

Device Story

ActivX is a manual, lightweight, folding wheelchair for mobility-impaired users. It features a sling seat and backrest on a frame supported by two large rear wheels and two forward swivel casters. The device incorporates a horizontal cross-brace mechanism to facilitate folding, distinguishing it from traditional vertical cross-brace designs. It supports accessories including removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks. Operated by the patient or an attendant, the device provides manual mobility in various settings. Clinical benefit is derived from restoring or enhancing independent or assisted locomotion for individuals with physical impairments.

Clinical Evidence

Bench testing only. Performance was validated using the ANSI/RESNA two-drum test to ensure structural integrity and durability of the horizontal cross-brace folding mechanism. Subject evaluations were also conducted to confirm acceptable performance.

Technological Characteristics

Manual folding wheelchair; horizontal cross-brace frame design; sling seat and backrest; two large rear wheels and two forward swivel casters. Features include removable armrests, detachable footrests, anti-tippers, and wheel locks. Mechanical operation; no energy source or software.

Indications for Use

Indicated for physically impaired individuals requiring mobility assistance via self-propulsion or attendant propulsion.

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.

Predicate Devices

• Quickie2 (K890050)

Submission Summary (Full Text)

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JAN 28

JAN 28 8 1999
510(K) - APRT - ActivX Wheelchair

1984367

## VI. 510(K) SUMMARY

| Submitter: | Adorno/Rogers Technology, Inc.<br>PO Box 160337<br>Austin, TX 78716<br>512-474-7267<br>Fax: [phone] |
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| Contact Person: | Paul Gibb |
| Date of Preparation: | December 3, 1998 |
| Common Name:<br>Proprietary Name:<br>Predicate Device: | Mechanical Folding Wheelchair (per 21 CFR section 890.3850)<br>ActivX<br>Quickie2 (K890050) |
| Intended Use: | Wheelchair mobility, either self-propelled or propelled by an<br>attendant, for the physically impaired. |
| Device Description: | The wheelchair is a standard lightweight manual folding chair that<br>provides mobility based on an individual user's needs and capabilities.<br>Since it has the same intended use as typical wheelchairs, its features<br>are also comparable. A sling seat and backrest are affixed to a sturdy<br>frame that is supported by two large rear wheels and two forward<br>swivel caster wheels. The two side frames are connected by a<br>horizontal cross brace, rather than a vertical cross brace, that can<br>assume a folded configuration. The wheelchair accommodates<br>removable armrests, detachable footrests, rear anti-tippers, push<br>handles, and wheel locks. |
| Comparison With<br>Predicate Device: | The ActivX wheelchair and the predicate device have an identical<br>intended use and are identical with respect to the way the user<br>propels and maneuvers the chair. The dimensions, construction<br>materials, and standard features/options of the two chairs are<br>substantially equivalent. The only difference between the A/RT<br>chair and the predicate device is in the way the chairs are opened and<br>folded. The A/RT chair has a horizontal cross brace, rather than the<br>typical vertical cross brace of most folding wheelchairs. This new<br>feature has been tested for Design Validation/Verification and has<br>performed acceptably. The results of the ANSI/RESNA two-drum<br>test and subject evaluations support a determination of "substantially<br>equivalent" for the ActivX wheelchair. |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 28 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Gibb Vice President and Chief Operating Officer Adorno/Rogers Technology, Inc. P.O. Box 160337 Austin, Texas 78716

K984367 Re: Trade Name: ActivX Regulatory Class: I Product Code: IOR December 3, 1998 Dated: Received: December 7, 1998

Dear Mr. Gibb:

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 reguirements 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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. Paul Gibb

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): K984367 Mechanical Folding Wheelchair - ActivX DEVICE NAME:

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INDICATIONS FOR USE:

## Intended Use:

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Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984367