---
kind: "section"
citation: "21 C.F.R. § 868.1040"
title: "21"
number: "868.1040"
heading: "Powered algesimeter."
url: "https://uscodex.org/cfr/21/868.1040"
---

# §868.1040. Powered algesimeter.

- (a) **Identification.** A powered algesimeter is a device using electrical stimulation intended to determine a patient's sensitivity to pain after administration of an anesthetic agent.
- (b) **Classification.** Class II (special 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).

## Notes

### Amendments

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]

### 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

[47 FR 31142, July 16, 1982, as amended at 84 FR 71811, Dec. 30, 2019]