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Stroke Rehab by Muscle Reeducation
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion

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The provided text is a 510(k) clearance letter from the FDA for a device named "AutoMove, model AM800." This letter determines that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter, not a study report or clinical trial summary. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory approval based on substantial equivalence, which means it compares the new device to existing approved devices without necessarily presenting a full clinical study with acceptance criteria and direct performance evaluation against those criteria.

Therefore, I cannot provide the requested information from the given text.

To obtain the information you're asking for, you would typically need to refer to:

• The original 510(k) submission document itself.
• Clinical study reports that would have been part of that submission or publicly published.
• The applicant's (Danmeter A/S) technical documentation or website.

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