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(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:

· for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping

• · to temporarily increase local blood circulation in healthy leg muscles
• · to stimulate healthy muscles in order to improve and facilitate muscle performance
• · to temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities legs) due to strain from exercise or normal household duties
• · for relaxation of muscle spasm,
• · for increase of blood flow circulation.
• · for prevention or retardation of disuse atrophy,
• · for muscle re-education,
• · for maintaining or increasing range of motion, and
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• · Provide quadricep strengthening
• · Improve knee stability secondary to quadricep strengthening

(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• · symptomatic relief and management of chronic, intractable pain
• · relief of pain associated with arthritis

· temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Revitive Medic Coach (Model Number 5575AQ). It outlines the device's indications for use and regulatory classifications, but does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the input text.

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NMES:

• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance.
• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
• For relaxation of muscle spasm.
• Increase of blood flow circulation,
• Prevention or retardation of disuse atrophy,
• Muscle re-education.
• Maintaining or increasing range of motion,
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping

TENS:

• For symptomatic relief and management of chronic intractable pain
• Relief of pain associated with arthritis
• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a powered muscle stimulator (Revitive Medic Plus, Revitive Advanced 2).

It includes:

• Device Name and Regulation Information: Identifies the device, its regulation number, and product codes.
• FDA Clearance Statement: States that the device is substantially equivalent to legally marketed predicate devices.
• General Controls Provisions: Mentions various regulatory requirements like annual registration, listing, good manufacturing practice, and labeling.
• Indications for Use: Details the intended medical uses for the device (NMES and TENS applications).

However, it does not contain any information about:

1. Acceptance Criteria Table: There is no table outlining specific performance metrics and their required thresholds.
2. Reported Device Performance: No actual study results or performance data are presented.
3. Sample Sizes and Data Provenance: No details about the size of test or training sets, or where the data came from (country, retrospective/prospective).
4. Expert Ground Truth Establishment: No information about the number or qualifications of experts used for ground truthing.
5. Adjudication Method: No mention of how ground truth disagreements were resolved.
6. MRMC Study: No indication that a multi-reader multi-case study was conducted, nor any effect size for human readers' improvement with AI.
7. Standalone Performance: No results for the algorithm's performance without human intervention.
8. Type of Ground Truth: No description of whether ground truth was based on expert consensus, pathology, or outcomes data.
9. Training Set Sample Size and Ground Truth Establishment: No information about the training set or how its ground truth was established.

This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed presentation of validation study results. To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) or a clinical study report, would be needed.

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NMES:

• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance.
• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities
• (arms) and lower extremities (legs) due to strain from exercise or normal household duties
• For relaxation of muscle spasm,
• Increase of blood flow circulation,
• Prevention or retardation of disuse atrophy,
• Muscle re-education,
• Maintaining or increasing range of motion, and
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

TENS:

• For symptomatic relief and management of chronic intractable pain

• Relief of pain associated with arthritis

• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities

Not Found

I am sorry but the provided document is a 510(k) summary for a powered muscle stimulator (Revitive Medic Plus, Revitive Advanced 2) that specifies its indications for use and classification. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

Therefore, I cannot provide the requested information based on this document.

Ask a specific question about this device

· To temporarily increase local blood circulation in healthy leg muscles

· To stimulate healthy muscles in order to improve and facilitate muscle performance.

· For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

Not Found

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the Revitive Medic, Revitive MV, and Revitive LV devices. This letter confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding:

• Specific acceptance criteria for performance.
• Details of any study proving device performance against acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, or expert involvement in any study.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device