(68 days)
The intended use of the CERAGEM – RH1 Automatic Thermal Massager is to provide the user with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- ◊ temporary relief of minor muscle and joint pain, and stiffness
- ُ the temporary relief of minor joint pain associated with arthritis
- the temporary increase in local circulation where applied
- 0 relaxation of muscles
The CERAGEM - RH1 Automatic Thermal Massager is an electrically powered motorized multi-functional physical therapy table. Its intended use is to provide muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by massage rollers mounted on an independent carriage underneath a pad on the table's torso section. The heat function is delivered by two components: 1) heated jade massage rollers mounted together on the moving carriage and 2) heated Epoxy Carbon Panels. In both cases, radiant infrared heat is emitted. Together, the massage action and heated pressure points apply light pressure as well as heat to the user.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the CERAGEM - RH1 Automatic Thermal Massager, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request for the tables and details about a study to prove acceptance criteria, as that information is not present in the given text.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).