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510(k) Data Aggregation
(111 days)
Ballancer 505 System, Model 1201-AC
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The Ballancer 505 System is indicated for:
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Simulating kneading and stroking of the tissues by use of an inflatable garment
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Temporary increase circulation in areas which the garment is applied
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Temporary relief of minor muscle aches and pains
Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The text is a letter from the FDA regarding a 510(k) premarket notification for the Ballancer 505 System, Model 1201-AC, and includes its indications for use. It does not include a detailed study report or acceptance criteria for device performance.
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