IQI — Orthosis, Limb Brace Class I
FDA Device Classification
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 | August 13, 2015 |
| K052771 | otto bock healthcare | SENSOR WALK | May 3, 2006 |
| K031576 | surgitech | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | July 31, 2003 |
| K926391 | regulatory and marketing services | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | July 22, 1993 |
| K910974 | mcconnell orthopedic | MCCONNELL SHOULDER BRACE | March 21, 1991 |
| K874502 | gait-aid | GAIT-AID ORTHOPEDIC INSOLE | November 30, 1987 |
| K831542 | fred sammons | ADJUSTABLE POLYCENTRIC ELBOW HINGE | June 24, 1983 |
| K831615 | edward dilauro, jr | DROP FOOT BRACE | June 15, 1983 |
| K823812 | danek medical | VARIOUS SUPPORTS AND SPLINTS | January 14, 1983 |
| K823113 | arco matic | BRACE-UP ALL PURPOSE WRIST BAND | November 16, 1982 |
| K823160 | warm and form, orthopedic materials | ROTATION BOOT | November 10, 1982 |
| K823114 | arco matic | BRACE-UP STOCKING KNEE BRACE | November 5, 1982 |
| K822767 | dynasplint systems | UNIVERSAL DYNASPLINT | October 6, 1982 |
| K822022 | ginny | SPORT SUPPORTS | July 26, 1982 |
| K821704 | hosmer dorrance | FRACTURE BRACING | June 24, 1982 |
| K821640 | fred sammons | ORTHOTIC FABRICATION ACCESSORIES | June 11, 1982 |
| K821641 | fred sammons | OBTHOSES | June 11, 1982 |
| K821582 | jerome medical | WARM'N FORM SPORTS SUPPORTS | June 10, 1982 |
| K820469 | thermo-mold medical products | WARM & FORM KNEE SUPPORTS | March 8, 1982 |
| K811704 | roger cestac and assoc | MULTITUBULAR AIR SPLINT KIT | July 1, 1981 |