(81 days)
Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied.
The Ballancer Gold is indicated for:
- · Simulate kneading and stroking of the tissues by use of an inflatable garment.
- · Temporary increase circulation in the areas which the garment is applied
- · Temporary relief of minor muscle aches and pains
Ballancer® Gold, Model 1212 is a pneumatic massage system.
This document is an FDA 510(k) clearance letter for the Ballancer® Gold, Model 1212. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to a predicate device and outlines regulatory compliance requirements.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory clearance rather than detailed performance study results.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).