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510(k) Data Aggregation
(133 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
TMC Electrical Scooter, Easy 411
The provided text is a 510(k) premarket notification letter from the FDA regarding a "TMC Electrical Scooter, Easy 411". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on:
- Confirming the substantial equivalence of the device to a predicate device.
- Outlining regulatory requirements for marketing the device.
- Stating the intended use of the device.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance and the methods used to evaluate it.
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(133 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Not Found
This is a 510(k) premarket notification for a medical device called "TMC Electrical Scooter, Easy 405." The document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a letter from the FDA to TMC Technology Corporation, stating that their device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements that the company must comply with. The enclosure mentions the "Indications for Use" for the device, which is "intended for medical purposes to provide mobility to persons restricted to a seated position."
Therefore, I cannot provide the requested information. This document is a regulatory approval letter, not a study report.
Ask a specific question about this device
(133 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Not Found
This document is a 510(k) clearance letter for a medical device: the "TMC Electrical Scooter, Easy 321." It primarily serves to inform the manufacturer that their device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.
While it mentions the device's intended use ("intended for medical purposes to provide mobility to persons restricted to a seated position"), it does not contain any information about acceptance criteria, device performance metrics, or any studies.
Therefore, I cannot provide the requested information. The document focuses solely on regulatory clearance based on substantial equivalence, not on specific performance data or studies.
Ask a specific question about this device
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