ILH · Splint, Hand, And Components
Physical Medicine · 21 CFR 890.3475 · Class 1
Overview
| Product Code | ILH |
|---|---|
| Device Name | Splint, Hand, And Components |
| Regulation | 21 CFR 890.3475 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
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 (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832144 | SPLINT WOOD | Vermont Wood Industries, Inc. | Aug 1, 1983 | SESE |
| K831548 | SPLINTS | Fred Sammons, Inc. | Jun 27, 1983 | SESE |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | Dec 30, 1982 | SESE |
| K823601 | WRIST SUPPORT | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823393 | STAX FINGER SPLINTS | Orthopedic Systems, Inc. | Dec 3, 1982 | SESE |
| K823165 | WRIST SPLING & FOREARM SPLINT | Warm & Form, Orthopedic Materials | Nov 16, 1982 | SESE |
| K822651 | TOTAL FINGER FLEXION SPLINT | Alimed, Inc. | Sep 17, 1982 | SESE |
| K821637 | WIRE-FOAM MP FLEXION SPRING | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K821635 | SOFT ULNAR DEVIATION SPLINTS | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K820826 | STAX FINGER SPLINT | Conco Medical Co. | Apr 8, 1982 | SESE |
| K820382 | FROG SPLINT | Conco Medical Co. | Mar 1, 1982 | SESE |
| K820381 | FINGER PROTECTOR | Conco Medical Co. | Mar 1, 1982 | SESE |
| K820380 | CURVED FINGER SPLINT | Conco Medical Co. | Mar 1, 1982 | SESE |
| K820383 | FINGER COT | Conco Medical Co. | Feb 24, 1982 | SESE |
| K812655 | VELCRO SPLINT STRAP FASTENERS | Maddak, Inc. | Sep 25, 1981 | SESE |
| K812654 | VELCRO FINGER/TOE SPLINT | Maddak, Inc. | Sep 25, 1981 | SESE |
| K812349 | HAND SPLINTS & COMPONENTS | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K810442 | HAND SPLINTS AND COMPONENTS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
Top Applicants
- Fred Sammons, Inc. — 21 clearances
- Conco Medical Co. — 5 clearances
- Maddak, Inc. — 2 clearances
- Warm & Form, Orthopedic Materials — 2 clearances
- Alimed, Inc. — 1 clearance
