← Product Code [LOF](/productcode/LOF) · P850007

# PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 (P850007)

_Orthofix, Inc. · LOF · Feb 21, 1986 · Orthopedic · APRL_

**Canonical URL:** https://fda.innolitics.com/device/P850007

## Device Facts

- **Applicant:** Orthofix, Inc.
- **Product Code:** [LOF](/productcode/LOF.md)
- **Decision Date:** Feb 21, 1986
- **Decision:** APRL
- **Regulation:** 21 CFR 890.5870
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.

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**Source:** [https://fda.innolitics.com/device/P850007](https://fda.innolitics.com/device/P850007)

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