(81 days)
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No
The summary describes a power tilt and recline seating system for pressure relief and positional change, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is intended to provide pressure relief and positional changes for individuals with various medical conditions and injuries, directly contributing to their therapeutic care and management of symptoms.
No
The device is described as a seating system designed for pressure relief through postural changes for individuals with various conditions, and its use is typically determined by a clinical evaluation. It does not perform any diagnostic functions.
No
The device description is not available, but the intended use clearly describes a "Power Tilt & Recline Seating System," which is a physical hardware device.
Based on the provided information, the TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device designed for pressure relief and positional change for individuals with various physical conditions. This involves supporting and positioning the body, which is a mechanical function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
The device is clearly intended for external use to support and reposition a person, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The profiles are arranged in a way that they appear to be interconnected. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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
2
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) |