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The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] 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 [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles

• [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy

The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy

The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] 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

The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] 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 [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles

• [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy

The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy

The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy

The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties

The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion

The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:

• [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] 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 - [4] Relief of post-surgical pain and post traumatic acute pain

The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion

The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] 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

The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance

The provided document is a 510(k) clearance letter from the FDA for a device called "Electrical Neuromuscular Stimulator, Cure Trio Models MC-310A, MC-310B," etc. This document states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It lists the indications for use for various models but does not delve into performance metrics, clinical study design, or results.

To answer your request thoroughly, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a substantial equivalence discussion document that typically accompanies 510(k) submissions.

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

Ask a specific question about this device

TENS:
1)The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
2) It is also intended to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS:

1. The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

This FDA 510(k) clearance letter for the Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) does not contain any information regarding specific acceptance criteria, device performance, or any studies.

The document is primarily an administrative letter from the FDA to Oriental Inspiration Limited, notifying them of the substantial equivalence (SE) determination for their device. It outlines:

• Device Name: Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous electrical nerve stimulator for pain relief
• Regulatory Class: Class II
• Product Code: NUH, NGX, NYN
• Indications for Use:
  • TENS: Temporary relief of pain associated with sore and aching muscles, and symptomatic relief and management of chronic, intractable pain and pain associated with arthritis.
  • EMS: Stimulate healthy muscles to improve and facilitate muscle performance.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information because it is not present in the provided text. To answer your questions, one would need to review the actual 510(k) submission document or related performance data, which is not included here.

Ask a specific question about this device