IQI — Orthosis, Limb Brace Class I
FDA product code IQI covers "Orthosis, Limb Brace", a Class I medical device regulated under 21 CFR 890.3475. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IQI
- Device Class
- Class I
- Regulation Number
- 890.3475
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143458 | Neurospectrum | Neurosplint | Aug 13, 2015 |
| K052771 | Otto Bock Healthcare | SENSOR WALK | May 3, 2006 |
| K031576 | Surgitech | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Jul 31, 2003 |
| K926391 | Regulatory And Marketing Services | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Jul 22, 1993 |
| K910974 | Mcconnell Orthopedic | MCCONNELL SHOULDER BRACE | Mar 21, 1991 |
| K874502 | Gait-Aid | GAIT-AID ORTHOPEDIC INSOLE | Nov 30, 1987 |
| K831542 | Fred Sammons | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Jun 24, 1983 |
| K831615 | Edward Dilauro, Jr | DROP FOOT BRACE | Jun 15, 1983 |
| K823812 | Danek Medical | VARIOUS SUPPORTS AND SPLINTS | Jan 14, 1983 |
| K823113 | Arco Matic | BRACE-UP ALL PURPOSE WRIST BAND | Nov 16, 1982 |
| K823160 | Warm And Form, Orthopedic Materials | ROTATION BOOT | Nov 10, 1982 |
| K823114 | Arco Matic | BRACE-UP STOCKING KNEE BRACE | Nov 5, 1982 |
| K822767 | Dynasplint Systems | UNIVERSAL DYNASPLINT | Oct 6, 1982 |
| K822022 | Ginny | SPORT SUPPORTS | Jul 26, 1982 |
| K821704 | Hosmer Dorrance | FRACTURE BRACING | Jun 24, 1982 |
| K821640 | Fred Sammons | ORTHOTIC FABRICATION ACCESSORIES | Jun 11, 1982 |
| K821641 | Fred Sammons | OBTHOSES | Jun 11, 1982 |
| K821582 | Jerome Medical | WARM'N FORM SPORTS SUPPORTS | Jun 10, 1982 |
| K820469 | Thermo-Mold Medical Products | WARM & FORM KNEE SUPPORTS | Mar 8, 1982 |
| K811704 | Roger Cestac And Assoc | MULTITUBULAR AIR SPLINT KIT | Jul 1, 1981 |