IQI · Orthosis, Limb Brace
Physical Medicine · 21 CFR 890.3475 · Class 1
Overview
| Product Code | IQI |
|---|---|
| Device Name | Orthosis, Limb Brace |
| 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 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143458 | Neurosplint | Neurospectrum, LLC | Aug 13, 2015 | SESE |
| K052771 | SENSOR WALK | Otto Bock Healthcare LP | May 3, 2006 | SESE |
| K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Surgitech, Inc. | Jul 31, 2003 | SESE |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Regulatory & Marketing Services, Inc. | Jul 22, 1993 | SESE |
| K910974 | MCCONNELL SHOULDER BRACE | Mcconnell Orthopedic | Mar 21, 1991 | SESE |
| K874502 | GAIT-AID ORTHOPEDIC INSOLE | Gait-Aid, Inc. | Nov 30, 1987 | SESE |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | Jun 24, 1983 | SESE |
| K831615 | DROP FOOT BRACE | Edward Dilauro, Jr. | Jun 15, 1983 | SESE |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823113 | BRACE-UP ALL PURPOSE WRIST BAND | Arco Matic, Inc. | Nov 16, 1982 | SESE |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | Nov 10, 1982 | SESE |
| K823114 | BRACE-UP STOCKING KNEE BRACE | Arco Matic, Inc. | Nov 5, 1982 | SESE |
| K822767 | UNIVERSAL DYNASPLINT | Dynasplint Systems, Inc. | Oct 6, 1982 | SESE |
| K822022 | SPORT SUPPORTS | Ginny, Inc. | Jul 26, 1982 | SESE |
| K821704 | FRACTURE BRACING | Hosmer Dorrance Corp. | Jun 24, 1982 | SESE |
| K821641 | OBTHOSES | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K821640 | ORTHOTIC FABRICATION ACCESSORIES | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jerome Medical | Jun 10, 1982 | SESE |
| K820469 | WARM & FORM KNEE SUPPORTS | Thermo-Mold Medical Products, Inc. | Mar 8, 1982 | SESE |
| K811704 | MULTITUBULAR AIR SPLINT KIT | Roger Cestac & Assoc. | Jul 1, 1981 | SESE |
Top Applicants
- Fred Sammons, Inc. — 7 clearances
- Orthomedics — 5 clearances
- Conphar, Inc. — 4 clearances
- Hosmer Dorrance Corp. — 3 clearances
- Aircast, Inc. — 2 clearances
