---
kind: "section"
citation: "21 C.F.R. § 882.4565"
title: "21"
number: "882.4565"
heading: "Field generator positioning device."
url: "https://uscodex.org/cfr/21/882.4565"
---

# §882.4565. Field generator positioning device.

- (a) **Identification.** A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.
- (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 [§ 882.9](/cfr/21/882.9.md).

## Notes

### Amendments

[90 FR 54234, Nov. 26, 2025]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[90 FR 54234, Nov. 26, 2025]