Pinwheel
The Pinwheel is a neurological examination instrument consisting of a small rolling wheel with evenly spaced pins, used by clinicians to test pain and light touch sensation across the skin surface, helping to map sensory deficits in peripheral neuropathy or spinal cord injury. It is an FDA Class 1 device, the lowest risk category, subject only to general controls with no premarket clearance required. Regulated under 21 CFR 882.1750 with product code GWY in the Neurology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GWY
- Device Class
- FDA class 1
- Regulation Number
- 882.1750
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Feb 24, 2005 | Substantially Equivalent | Aspect Medical Systems, Inc. |
| K942926 | NEURO-AIDE | Aug 03, 1994 | Substantially Equivalent | Burke Neutech, Inc. |
| K871167 | SENSITESTER | Apr 01, 1987 | Substantially Equivalent | Dexin Pty. , Ltd. |
| K851749 | 1-380 PINWHEEL (WARTENBERG) | Jun 13, 1985 | Substantially Equivalent | Artiberia |
| K780422 | PINWHEEL | Apr 04, 1978 | Substantially Equivalent | Projects IN Health |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.