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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 888Subpart E → §888.5850


Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart E—Surgical Devices


§888.5850   Nonpowered orthopedic traction apparatus and accessories.

(a) Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

(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 §888.9. 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, regarding general requirements concerning records, and §820.198, regarding complaint files.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]

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