INT · Plinth
Physical Medicine · 21 CFR 890.3520 · Class 1
Overview
| Product Code | INT |
|---|---|
| Device Name | Plinth |
| Regulation | 21 CFR 890.3520 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.
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 § 890.9. 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 |
|---|---|---|---|---|
| K770723 | TABLE, TREATMENT, THERAPY, PHYSICAL | Chattanooga Pharmacal Co. | Jul 11, 1977 | SESE |
| K770636 | TABLE, EXAM & MANUPULATION | I E Industries | Apr 15, 1977 | SESE |
| K770609 | TABLE, MASSAGE & TREATMHNT, FIXED HEIGHT | Will Ross Co. | Apr 8, 1977 | SESE |
| K770509 | TABLE, MASSAGE AND TREATMENT | Will Ross Co. | Apr 5, 1977 | SESE |
Top Applicants
- Will Ross Co. — 2 clearances
- Chattanooga Pharmacal Co. — 1 clearance
- I E Industries — 1 clearance
