(87 days)
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Not Found
No
The summary describes a power base chair for disabled people and does not mention any AI or ML capabilities.
No
This device is described as a "handicap piece of equipment" used "to assist disabled people to negotiate their daily living," specifically people with muscular disease to "improve their daily living." This aligns with the definition of a mobility aid or assistive device, which helps with daily activities but does not directly treat or cure a medical condition.
No
The provided text describes a "handicap piece of equipment" used to "assist disabled people to negotiate their daily living" and "improve their daily living," which points to a device for assistance and daily living improvement, not for diagnosing medical conditions.
No
The device description explicitly states "MP-3 Power Base Chair," indicating a physical hardware component. The intended use also describes a "handicap piece of equipment" and a "chair," further confirming it is not software-only.
Based on the provided information, the Merits Health Products MP3 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "handicap piece of equipment... used to assist disabled people to negotiate their daily living." This clearly indicates a device used on the body for mobility and assistance, not for testing samples outside the body to diagnose or monitor medical conditions.
- Device Description: "MP-3 Power Base Chair" further supports the description of a mobility aid.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing or monitoring diseases
- Using reagents or laboratory procedures
Therefore, the Merits Health Products MP3 is a mobility device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.
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
Not Found
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
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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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight. The birds are arranged in a vertical stack, with the largest bird at the top and the smallest bird at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 5 1999
Mr. Winston Anderson Vice President Merits Health Products, Inc. P.O. Box 150356 Cape Coral, Florida 33915
Re: K993032 Modification to MP-3 Power Base Chair Trade Name: Regulatory Class: II Product Code: ITI Dated: Undated Received: August 10, 1999
Dear Mr. Anderson:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, 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 requlations.
1
Page 2 - Mr. Winston Anderson
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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K993032 |
|---|---|
| Device Name: | MP3 |
Indications For Use:
November 4, 1999
Dear Sir:
Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.
Yours truly,
Win Andu
Winston Anderson, Vice President Merits Health Products
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Concurrence of CDRH, Office of Device Evaluation (ODE).
(Division Sign-Off)
Division of General Restorative Devices K993032
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)