FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300

K983066 · Teftec Corp. · ITI · Nov 27, 1998 · Physical Medicine

Device Facts

• Record ID: K983066
• Device Name: FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
• Applicant: Teftec Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TEFTEC Corporation FirstClass™ Power Tilt Seating System has been designed for use by anyone needing pressure relief while in a seated position. The First Class™ Power Tit Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Scierosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list. Anyone needing pressure relief or positional change that is unable to facilitate those movements independently, would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

Device Story

FirstClass™ Power Tilt Seat System Model S300 is a powered seating system designed to provide pressure relief through postural change. The device is intended for patients unable to independently shift weight or reposition while seated. It functions as an assistive mobility accessory, allowing users to tilt the seat to redistribute pressure, thereby potentially reducing the risk of pressure sores or complications associated with prolonged immobility. The system is operated by the user or a caregiver to adjust seating angles. It is used in clinical or home environments to facilitate positional changes based on a clinician's assessment of the patient's strength, sensation, and mobility requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered tilt seating system; electromechanical actuation for postural adjustment. Designed for integration with seating platforms. Class II device (Product Code: ITI).

Indications for Use

Indicated for individuals requiring pressure relief or postural change while seated due to inability to perform movements independently. Applicable to patients with conditions including SCI, TBI, MD, CP, CVA, ALS, chronic pain, burn trauma, or other mobility/seating needs determined by clinical evaluation.

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)

{0}------------------------------------------------

NOV 2 7 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas E. Finch, III Vice President Teftec Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070

Re: K983066 FirstClass™ Powered Tilt Seat Trade Name: System, Model S300 Requlatory Class: II Product Code: ITI Dated: August 19, 1998 September 2, 1998 Received:

Dear Mr. Finch:

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 Requlations, 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 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.

{1}------------------------------------------------

Page 2 - Mr. Thomas E. Finch, III

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 requlation (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

{2}------------------------------------------------

Page 1 of 1

## 510 (k) NUMBER (IF KNOWN): K983066

DEVICE NAME:

FirstClass™ Power Tilt Seat System Model \$300

INDICATIONS FOR USE:

The TEFTEC Corporation FirstClass™ Power Tilt Seating System has been designed for use by anyone needing pressure relief while in a seated position.

The First Class™ Power Tit Seating System could provide pressure relief by postural change for persons having the following condition or injury:

Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Scierosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke)

This is not meant to be an all-inclusive list. Anyone needing pressure relief or positional change that is unable to facilitate those movements independently, would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

## (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 |
|------------------------------------------|----------------------------|
| | (Optional Format 1 2 - 96) |

| Revised 11/13/1998 | (Division/Sign-Off) |
|--------------------|-----------------------------------------|
| | Division of General Restorative Devices |
| 510(k) Number | K983066 |