IQM · Splint, Temporary Training
Physical Medicine · 21 CFR 890.3025 · Class 1
Overview
| Product Code | IQM |
|---|---|
| Device Name | Splint, Temporary Training |
| Regulation | 21 CFR 890.3025 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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 |
|---|---|---|---|---|
| K771287 | FINGEO EXTENSION SPLINTS | Fred Sammons, Inc. | Jul 21, 1977 | SESE |
| K770891 | SPLINH, FOREARM | Orthopedic Systems, Inc. | May 26, 1977 | SESE |
| K770890 | SPLINT, COCKUP | Orthopedic Systems, Inc. | May 26, 1977 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 2 clearances
- Fred Sammons, Inc. — 1 clearance
