Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart B — Diagnostic Devices](/submissions/OR/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 888.1520](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1520) → LZE — Isometer

# LZE · Isometer

_Orthopedic · 21 CFR 888.1520 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE

## Overview

- **Product Code:** LZE
- **Device Name:** Isometer
- **Regulation:** [21 CFR 888.1520](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/888.1520)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950178](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE/K950178.md) | PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET | Pharma-Plast Intl. A/S | Jul 17, 1995 | SESE |

## Top Applicants

- Pharma-Plast Intl. A/S — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE)

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