21 CFR § 888.5960 - Cast removal instrument.

---
identifier: "/us/cfr/t21/s888.5960"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.5960 - Cast removal instrument."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.5960"
section_name: "Cast removal instrument."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 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.

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