---
kind: "section"
citation: "21 C.F.R. § 868.1030"
title: "21"
number: "868.1030"
heading: "Manual algesimeter."
url: "https://uscodex.org/cfr/21/868.1030"
---

# §868.1030. Manual algesimeter.

- (a) **Identification.** A manual algesimeter is a mechanical device intended to determine a patient's sensitivity to pain after administration of an anesthetic agent, e.g., by pricking with a sharp point.
- (b) **Classification.** Class I (general controls). The device is 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 [§ 868.9](/cfr/21/868.9.md). The 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

[54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025]

### Authority

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

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.

### Amendments

[54 FR 25048, June 12, 1989, as amended at 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025]