(63 days)
For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)
For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)
For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Mode P4)
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "PlayMakar Sport Muscle Stimulator, Model PRO-500." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document includes:
- Trade/Device Name: PlayMakar Sport Muscle Stimulator, Model PRO-500
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Product Code: NUH, NYN, NYN, NGX
- Indications for Use:
- For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
- For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
- For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
- For symptomatic relief and management of chronic, intractable pain associated with arthritis.
- Type of Use: Over-The-Counter Use
Missing Information:
The document explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices. This type of clearance generally relies on demonstrating similarity in technological characteristics and performance to already legally marketed devices, rather than requiring new clinical studies to establish acceptance criteria for novel performance claims.
Therefore, I cannot provide the requested information, which typically pertains to performance studies and acceptance criteria for a device. This document does not describe such studies or criteria.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).