---
kind: "section"
citation: "21 C.F.R. § 886.1140"
title: "21"
number: "886.1140"
heading: "Ophthalmic chair."
url: "https://uscodex.org/cfr/21/886.1140"
---

# §886.1140. Ophthalmic chair.

- (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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 886.9](/cfr/21/886.9.md). The manual device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[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]