# Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
> **Food and Drug Administration** · Final amendment; final order. · Published 2026-04-16 · Effective 2026-05-18 · 91 FR 20352
## Document
- **Document number:** 2026-07366
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 91 FR 20352
- **CFR reference:** 21 CFR 890
- **Publication date:** 2026-04-16
- **Effective date:** 2026-05-18
- **HHS docket:** Docket No. FDA-2020-N-1053
## Abstract

The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators)
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