(420 days)
Not Found
Not Found
No
The summary describes a motorized scooter for transportation and does not mention any AI or ML capabilities.
No
The device is described as a motorized three-wheeled scooter intended for transportation, primarily for disabled persons, and does not claim any therapeutic function.
No
Explanation: The device is described as a "MOTORIZED THREE-WHEELED SCOOTER" intended to "transport person outside usually by disabled persons." There is no indication or mention of it being used for diagnosis, detection, or monitoring of any medical condition.
No
The device description clearly states it is a "MOTORIZED THREE-WHEELED SCOOTER," which is a physical hardware device.
Based on the provided information, the TMC-Easy-302 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "to transport person outside usually by disabled persons." This is a physical mobility aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description is of a "MOTORIZED THREE-WHEELED SCOOTER," which aligns with a transportation device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, the TMC-Easy-302 is a mobility device and does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.
The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 20 miles.
Product codes
INI
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
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Key Metrics
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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
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing right, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
TMC Magnetics & Machinery Corporation C/o Ms. Susan D. Goldstein-Falk MDI Consultants 55 Northern Boulevard Great Neck, New York 11021
Re: K984565
Trade Name: TMC Easy-302 Motorized Three-Wheeled Scooter Regulatory Class: II Product Code: INI Dated: February 8, 2000 Received: February 10, 2000
Dear Ms. Goldstein-Falk:
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.
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.
1
Page 2 -- Ms. Susan D. Goldstein-Falk
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.
Mark N. Millman
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for use
510(k) NUMBER (IF KNOW): _____________________________________________________________________________________________________________________________________________________
DEVICE NAME: TMC-Easy-302 MOTORIZED THREE-WHEELED SCOOTER INDICATION FOR USE:
TMC-Easy-302 is intended for use to transport person outside usually by disabled persons. The scooter has a seated position for carrying person in the considerations of ergonomically.
The scooter's range on a standard charge varies according to temperature and battery condition, but the average range is approximately 20 miles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR Over-The-Counter-Use
(Optional Format 1-2-96)
Mark-N-Mullins
fion
(Division Sign-Off) Division of General Restorative Devices 510(k) Number