CFR

880.5780—Medical support stocking.

(a) Medical support stocking to prevent the pooling of blood in the legs— (1) Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.

(2) Classification. Class II (performance standards).

(b) Medical support stocking for general medical purposes— (1) Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.

(2) Classification. Class I. 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 is also exempt from the current good manufacturing practice requirements of the quality system regulation 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.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]

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