LZE · Isometer
Orthopedic · 21 CFR 888.1520 · Class 1
Overview
| Product Code | LZE |
|---|---|
| Device Name | Isometer |
| Regulation | 21 CFR 888.1520 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950178 | 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
