← Product Code [IPG](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPG) · K780617

# EQUALIZER (K780617)

_Ballert Orthopedic Corp. · IPG · Apr 18, 1978 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPG/K780617

## Device Facts

- **Applicant:** Ballert Orthopedic Corp.
- **Product Code:** [IPG](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPG.md)
- **Decision Date:** Apr 18, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3025
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPG/K780617](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPG/K780617)

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