← Product Code [LZE](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE) · K950178

# PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET (K950178)

_Pharma-Plast Intl. A/S · LZE · Jul 17, 1995 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE/K950178

## Device Facts

- **Applicant:** Pharma-Plast Intl. A/S
- **Product Code:** [LZE](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE.md)
- **Decision Date:** Jul 17, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1520
- **Device Class:** Class 1
- **Review Panel:** Orthopedic

## Regulatory Identification

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

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE/K950178](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/LZE/K950178)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com