(28 days)
Hydrotherapy; Professional footbath for a relaxing aqua massage. Ideal for pedicure preparation. Gently massages soles of feet, comforts soles of feet, soothing relief for tired feet.
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This document is a marketing clearance letter from the FDA for the Windmere Model DS-2 Foot Bath (K980769). This type of document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means that the device is deemed safe and effective for its intended use based on its similarity to previously cleared devices, rather than through a direct study demonstrating its performance against specific acceptance criteria.
The "Indications for Use" section (page 2) describes what the foot bath is intended for (Hydrotherapy; Professional footbath for a relaxing aqua massage, etc.) and lists contraindications, but these are not performance metrics or acceptance criteria for a study.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.