ITO · Twister, Brace Setting
Physical Medicine · 21 CFR 890.3410 · Class 1
Overview
| Product Code | ITO |
|---|---|
| Device Name | Twister, Brace Setting |
| Regulation | 21 CFR 890.3410 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K800716 | ORTHOTIC LEG GAIT CORRECTOR DEVICE | Ipos Luneburg | May 2, 1980 | SESE |
Top Applicants
- Ipos Luneburg — 1 clearance
