Fork, Tuning
The Tuning Fork is a simple neurological and physical examination instrument used to assess vibration sense and hearing by generating a specific acoustic frequency when struck, aiding in bedside evaluation of sensory neuropathy and conductive versus sensorineural hearing loss. It is an FDA Class 1 device subject only to general controls, and it is GMP exempt. The product code is GWX, regulated under 21 CFR 882.1525 in the Neurology specialty. No other special flags apply to this device.
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Basic Information
- Product Code
- GWX
- Device Class
- FDA class 1
- Regulation Number
- 882.1525
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874966 | TUNING FORKS | Jan 04, 1988 | Substantially Equivalent | Solway, Inc. |
| K813304 | CONPHAR, TUNING FORKS | Dec 10, 1981 | Substantially Equivalent | Conphar, Inc. |
| K761132 | TUNING FORK | Dec 02, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
| K760303 | FORK, TUNING BK-7519 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 128 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 128 registration numbers. Click on an entry to view related FDA registrations.