(81 days)
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No
The summary describes a power recline seating system for pressure relief and positional change, with no mention of AI or ML technology in the intended use, device description, or any other section.
Yes
The device is designed to provide pressure relief and positional change for individuals with various medical conditions, indicating a therapeutic purpose to alleviate symptoms or improve physical well-being.
No
This device is a seating system designed for pressure relief and postural changes, indicated for conditions like spinal cord injury or muscular dystrophy. Its purpose is therapeutic and supportive, not for diagnosing medical conditions.
No
The device description explicitly refers to a "Power Recline Seat System Model S500," which is a physical hardware product, not software.
Based on the provided information, the TEFTEC Corporation FirstClass™ Power Recline Seating System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Power Recline Seating System" designed for "pressure relief while in a seated position" and to facilitate "positional change." It is a physical device used externally on the body.
- Intended Use: The intended use is to provide pressure relief and positional change for individuals with various physical conditions that limit their ability to move independently. This is a therapeutic and assistive function, not a diagnostic one.
The device's purpose is to provide physical support and facilitate movement, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The TEFTEC Corporation FirstClass™ Power Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.
The FirstClass™ Power 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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Mr. Tom Finch President TEFTEC Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070
Re: K992627
Trade Name: FirstClass™ Power Recline Seat System Model S500 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):
DEVICE NAME:
FirstClass™ Power Recline Seat System Model S500
INDICATIONS FOR USE:
The TEFTEC Corporation FirstClass™ Power Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.
The FirstClass™ Power 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 Linc-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 | K992627 | |
| (Division Sign-Off) Division of General Restorative Devices 510(k) Number | ||
| Prescription Use (Per 21 CFR 804:109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) |