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Apparatus, Traction, Non-Powered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.5850
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.5850 Nonpowered orthopedic traction apparatus and accessories

§ 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]

Apparatus, Traction, Non-Powered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.5850
GMP Exempt?
Yes
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.5850 Nonpowered orthopedic traction apparatus and accessories

§ 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]