GWI · Discriminator, Two-Point
Neurology · 21 CFR 882.1200 · Class 1
Overview
| Product Code | GWI |
|---|---|
| Device Name | Discriminator, Two-Point |
| Regulation | 21 CFR 882.1200 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| GMP Exempt | Yes |
Identification
A two-point discriminator is a device with points used for testing a patient's touch discrimination.
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. 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944234 | TCD OR TCD NEUROPATHY STAR | Jcm Management & Planning Co. | Mar 8, 1995 | SESE |
| K874300 | AESTHESIOMETER | Orthopedic Systems, Inc. | Nov 6, 1987 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 1 clearance
- Jcm Management & Planning Co. — 1 clearance
