(81 days)
The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.
The FirstClass™ Power Tilt & Recline 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 Sclerosis 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.
Not Found
The provided document is a 510(k) summary for the FirstClass™ Power Tilt & Recline Seat System Model S400. It is a clearance letter from the FDA stating that the device is substantially equivalent to a predicate device.
This document does NOT contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, or any of the detailed study parameters requested.
The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices. It does not provide any clinical trial data, performance metrics, or study designs typically associated with proving a device meets specific acceptance criteria.
Therefore, I cannot populate the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Mr. Tom Finch President TEFTEC Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070
Re: K992628
Trade Name: FirstClass™ Power Tilt and Recline Seat System Model S400 Regulatory Class: II Product Code: ITI Dated: August 3, 1999 Received: August 5, 1999
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 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. Thomas Finch
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
:
510 (k) NUMBER (IF KNOWN): K992628
DEVICE NAME:
FirstClass™ Power Tilt & Recline Seat System Model S400
INDICATIONS FOR USE:
The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.
The FirstClass™ Power Tilt & Recline 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 Sclerosis 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) | ||
|---|---|---|
| (Division Sign-Off | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K992628 | |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter-Use(Optional Format 1 - 2/96) |
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).