(94 days)
TENS (Transcutaneous Electric Nerve Stimulation): 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. EMS (Electric Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
This document is a 510(k) clearance letter for the TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets those criteria.
The letter is primarily focused on:
- 510(k) Clearance: Confirming the device's substantial equivalence to predicate devices.
- Regulatory Information: Specifying the regulation number, name, regulatory class, and product code.
- General Controls: Reminding the manufacturer of their obligations under the Act (registration, listing, GMP, labeling, etc.).
- Indications for Use: Detailing the intended uses for both the TENS and EMS functions of the device.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies from this document. This type of detail would typically be found in the 510(k) submission itself, which is not provided here.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).