Source: http://www.low-g.com/index.php?id=17
Timestamp: 2019-02-16 13:41:48
Document Index: 786113982

Matched Legal Cases: ['§ 880', '§ 880', 'art 807', '§ 880', 'art 820', '§ 820', '§ 820', '§ 880', '§ 880', '§ 880']

The Low-G® Skin Pressure Protection System is a family of products intended to be used for medical purposes to reduce pressure on the skin. Low-G products are non-powered flotation therapy devices made specifically to reduce the factors that lead to the formation of decubitus ulcers (bedsores). Given the intended uses of The Low-G Skin Pressure Protection System, it qualifies as a medical device pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying regulations.
With the assistance of expert panels and comments of industry and the public, the Center for Devices and Radiological Health (CDRH), the component of the Food and Drug Administration that regulates medical devices, has classified all types of medical devices into one of three classes in regulations in the Code of Federal Regulations. The classification of a device determines the extent of regulations to which it is subject. The Low-G Skin Pressure Protection System line of products satisfies every element in the identification of a “Nonpowered flotation therapy mattress” in the classification regulation located in 21 CFR § 880.5150, and a “Skin pressure protector” in the classification regulation located in 21 CFR § 880-6450.
Section 880.5150 Nonpowered flotation therapy mattress.
(a) Identification. A non-powered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bedsores).
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
Section 880.6450 A skin pressure protector.
(a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient’s developing decubitus ulcers (bedsores).
The criteria for exemption in § 880.9, as applied to the Low-G Skin Pressure Protection System, are:
The Low-G Skin Pressure Protection System has the characteristics of commercially distributed devices within the generic type.
The intended use for the Low-G Skin Pressure Protection System is the same as legally marketed non-powered flotation therapy mattresses and skin pressure protectors.
The Low-G Skin Pressure Protection System uses the same technology that is used in similar devices.
The Low-G® Skin Pressure Protection System meets all the requirements of 21 CFR § 880.5150 and 21 CFR § 880.6450 so long as Low-G and its contracted manufacturer complies with the record retention and complaint file portions of the GMP (now QSM) regulation.
Oregon Aero, Inc., the contracted manufacturer for The Low-G® Skin Pressure Protection System line of products, has registered with the FDA as a medical device manufacturer as required under regulations.
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