(90 days)
SM9089:
TENS(3,4,5,6,8,15,19,21):
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.
PMS(1,2,7,9,10,11,12,13,14,16,17,18,20,22,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9587:
TENS(3.4.5.6 8.11.15.16.19.21.22):
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.
PMS(1,2,7,9,10,12,13,14,17,18,20,23,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9592:
TENS(2,3,4,5,7,9,10,19,21,22,24):
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.
PMS(1,6,8,11,12,13,14,15,16,17,18,20,23):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM9555:
TENS(3-6, 13,14,19-21,23):
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.
PMS(1,2,7-12,15-18,22,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
The provided document is an FDA 510(k) clearance letter for Transcutaneous Electrical Nerve Stimulators (TENS) and Powered Muscle Stimulators (PMS) devices. It confirms that the devices are substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The letter primarily addresses regulatory clearance based on substantial equivalence to existing devices, general controls provisions of the Federal Food, Drug, and Cosmetic Act, and specifies the Indications for Use for various models.
For a device's performance to be evaluated against acceptance criteria, a clinical study or performance testing data would typically be required to be referenced in the submission. This information is usually found in the 510(k) summary or the detailed technical documentation submitted to the FDA, which is not part of this public clearance letter.
Therefore, I cannot provide the requested details using only the provided text. The document is a regulatory approval, not a performance study report.
§ 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).