KQW · Goniometer, Nonpowered
Orthopedic · 21 CFR 888.1520 · Class 1
Overview
| Product Code | KQW |
|---|---|
| Device Name | Goniometer, Nonpowered |
| 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.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926237 | O'BRIEN GONIOMETER | Sgarlato Laboratories, Inc. | Aug 2, 1993 | SESE |
| K901744 | DOBBHOFF(R) RETRIEVAL FORCEPS | Biosearch Medical Products, Inc. | Jul 3, 1990 | SESE |
| K870767 | THE (CROM) TESTER | Twin City Surgical, Inc. | Mar 17, 1987 | SESE |
| K850082 | HAND HELD GONIOMETER | Chattanooga Group, Inc. | Apr 4, 1985 | SESE |
| K831550 | FINGER BONIOMETER BK7506 | Fred Sammons, Inc. | Jun 24, 1983 | SESE |
| K812778 | THE TELOS EQUIPMENT | The Telos Co. | Dec 8, 1981 | SESE |
| K810441 | UNIVERSAL GONIMETER | Fred Sammons, Inc. | Feb 27, 1981 | SESE |
| K801718 | BK-7513 STAINLESS STEEL GONIOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| K801717 | BK-7511 BRASS GONIOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| K801716 | BK-7505 RADIOPAQUE GONIOMETER, 8 | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| K801715 | BK-7497 BULB DYNAMOMETER | Fred Sammons, Inc. | Aug 4, 1980 | SESE |
| K760302 | GONIOMETER, INTER. STAND. LARGE, BK7514 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
| K760301 | GONIOMETER, MED. INTER. STAND. BK-7512 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 8 clearances
- Biosearch Medical Products, Inc. — 1 clearance
- Chattanooga Group, Inc. — 1 clearance
- Sgarlato Laboratories, Inc. — 1 clearance
- The Telos Co. — 1 clearance
