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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.

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