ITN · Splint, Denis Brown
Physical Medicine · 21 CFR 890.3675 · Class 1
Overview
| Product Code | ITN |
|---|---|
| Device Name | Splint, Denis Brown |
| Regulation | 21 CFR 890.3675 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071028 | VIEWMATE SYSTEM | Ep Medsystems | May 1, 2007 | SESE |
| K032669 | Y.E.S. POWERED WHEELCHAIR, MODEL T200 | Yeou Eir Shuen Machinery Co., Ltd. | Nov 12, 2003 | SESE |
| K821256 | COUNTER-ROTATION SYSTEM | The Langer Group | Jun 23, 1982 | SESE |
Top Applicants
- Ep Medsystems — 1 clearance
- The Langer Group — 1 clearance
- Yeou Eir Shuen Machinery Co., Ltd. — 1 clearance
