21 CFR 890.3150 — Crutch

Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3150

Identification

A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

Classification Rationale

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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IPRCrutch14
Innolitics

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