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Code · CFR · Title 21 — Food and Drugs · Part 886 — Ophthalmic Devices · § 886.1140

§ 886.1140. Ophthalmic chair.

128 words·~1 min read·/us/cfr/t21/s§ 886.1140·

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(a)Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.
(b)Classification. Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The manual 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. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 90 FR 55989, Dec. 4, 2025]
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