888.5960—Cast removal instrument.

(a) Identification. A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

(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.

Code of Federal Regulations

[55 FR 48443, Nov. 20, 1990, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]

CFR

888.5960—Cast removal instrument.

Code of Federal Regulations