GWY · Pinwheel
Neurology · 21 CFR 882.1750 · Class 1
Overview
| Product Code | GWY |
|---|---|
| Device Name | Pinwheel |
| Regulation | 21 CFR 882.1750 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.
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 § 882.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Aspect Medical Systems, Inc. | Feb 24, 2005 | SESE |
| K942926 | NEURO-AIDE | Burke Neutech, Inc. | Aug 3, 1994 | SESE |
| K871167 | SENSITESTER | Dexin Pty. , Ltd. | Apr 1, 1987 | SESE |
| K851749 | 1-380 PINWHEEL (WARTENBERG) | Artiberia | Jun 13, 1985 | SESE |
| K780422 | PINWHEEL | Projects IN Health | Apr 4, 1978 | SESE |
Top Applicants
- Artiberia — 1 clearance
- Aspect Medical Systems, Inc. — 1 clearance
- Burke Neutech, Inc. — 1 clearance
- Dexin Pty. , Ltd. — 1 clearance
- Projects IN Health — 1 clearance
