(42 days)
Not Found
Not Found
No
The summary does not mention any terms related to AI or ML, nor does it describe functionalities that would typically require such technologies for a powerchair.
No
Explanation: A therapeutic device is used to treat, cure, or prevent a disease or to restore, correct, or modify physiological functions. A powerchair, as described, provides mobility but does not fit the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" states the device is to "provide mobility to persons limited to a seated position," which describes a mobility aid, not a diagnostic tool.
No
The device description clearly identifies it as a "Powerchair," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide mobility to persons limited to a seated position." This clearly describes a device used on a person for physical assistance, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a medical condition.
- Device Description: A "Powerchair" is a mobility aid, not a diagnostic tool.
- Lack of IVD-related information: The document lacks any mention of:
- Image processing, AI, DNN, or ML (often used in diagnostic imaging or analysis).
- Input imaging modality (relevant for imaging-based diagnostics).
- Anatomical site (relevant for devices targeting specific body parts for diagnosis).
- Performance studies, key metrics, predicate/reference devices (all standard information for IVD submissions).
Therefore, the Hoveround SE-3 Powerchair, as described, is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is to provide mobility to persons limited to a seated position.
Product codes
ITI
Device Description
Hoveround SE-3 Powerchair
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Mr. Tony DiGiovanni Director of Engineering Hoveround Corporation 2151 Whitfield Industrial Way Sarasota, Florida 34243
Re: K042920
Ro42920
Trade/Device Name: Hoveround SE-3 Powerchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: October 21, 2004 Received: October 22, 2004
Dear Mr. DiGiovanni:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is substantised in interstate referenced above and nave ecelimined the actrise to bedicate devices marketed in interstate for use stated in the enclosure) to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment day its the Federal Food. Drue, commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while in the proval application (PMA).
and Cosmetic Act (Act) that do not require approval astroly sources of the Act . The and Cosmetic Act (Act) that do not require approval or the general controls provisions of the Act. The You may, therefore, market the device, subject to tire general registration, listing of
general controls provisions of the Act include required it' its asseinst misbranding a general controls provisions of the Act mender requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more in the startering your device can
may be subject to such additional controls. Title of to 900 to 808 - In addition FDA may may be subject to such additional controlis. Existing may or 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peachartergening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issialice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decidination that your acceral agencies. You must ation and ligit or any Federal Statutes and regulations administered of othinited to: registration and listing (21 l comply with and the Act 3 requirements, mercains, and manufacturing practice requirements as setting destrong CFR Part 807); labening (21 CFR Part 807); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicabl forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Tony DiGiovanni
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket nothcation: "The PDF miaing of easification 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), please If you desire specific advice for Jour at 10-10-20120. Also, please note the regulation entitled, p Colliact the Office of Compunes and (21 transmit (21CFR Part 807.97). You may obtain Missuranuing of Icrerchee to premail.orgibilities under the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or Manufacturers, International and Ooness http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Melleman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510k number (if known): K
Hoveround SE-3 Powerchair Device Name:
The intended use is to provide mobility to persons limited Indications For Use: to a seated position.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millerson
Division of General. Restorative, and Neurological Devices
Page 1 of __
51 Number K042920