GWX · Fork, Tuning
Neurology · 21 CFR 882.1525 · Class 1
Overview
| Product Code | GWX |
|---|---|
| Device Name | Fork, Tuning |
| Regulation | 21 CFR 882.1525 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| GMP Exempt | Yes |
Identification
A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.
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 § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874966 | TUNING FORKS | Solway, Inc. | Jan 4, 1988 | SESE |
| K813304 | CONPHAR, TUNING FORKS | Conphar, Inc. | Dec 10, 1981 | SESE |
| K761132 | TUNING FORK | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
| K760303 | FORK, TUNING BK-7519 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 2 clearances
- Conphar, Inc. — 1 clearance
- Solway, Inc. — 1 clearance
