Panels › Physical Medicine › Product code IQI · Class 1
Orthosis, Limb Brace
Regulation 890.3475
0510(k)s in 12 months (52 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in IQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Fred Sammons, Inc. | 7 | 0 |
| Ossur H / F | 0 | 7 |
| Orthomedics | 5 | 0 |
| Conphar, Inc. | 4 | 0 |
| Hosmer Dorrance Corp. | 3 | 0 |
| Townsend Design | 0 | 3 |
| 3M Company - Health Care Business | 0 | 2 |
| Aircast, Inc. | 2 | 0 |
| Arco Matic, Inc. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2015 | K143458 | Neurosplint Neurospectrum, LLC | IQI |
| May 3, 2006 | K052771 | SENSOR WALK Otto Bock Healthcare LP | IQI |
| Jul 31, 2003 | K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 Surgitech, Inc. | IQI |
| Jul 22, 1993 | K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS Regulatory & Marketing Services, Inc. | IQI |
| Mar 21, 1991 | K910974 | MCCONNELL SHOULDER BRACE Mcconnell Orthopedic | IQI |
| Nov 30, 1987 | K874502 | GAIT-AID ORTHOPEDIC INSOLE Gait-Aid, Inc., CA | IQI |
| Jun 24, 1983 | K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE Fred Sammons, Inc. | IQI |
| Jun 15, 1983 | K831615 | DROP FOOT BRACE Edward Dilauro, Jr. | IQI |
| Jan 14, 1983 | K823812 | VARIOUS SUPPORTS AND SPLINTS Danek Medical, Inc. | IQI |
| Nov 16, 1982 | K823113 | BRACE-UP ALL PURPOSE WRIST BAND Arco Matic, Inc. | IQI |
| Nov 10, 1982 | K823160 | ROTATION BOOT Warm & Form, Orthopedic Materials | IQI |
| Nov 5, 1982 | K823114 | BRACE-UP STOCKING KNEE BRACE Arco Matic, Inc. | IQI |
| Oct 6, 1982 | K822767 | UNIVERSAL DYNASPLINT Dynasplint Systems, Inc. | IQI |
| Jul 26, 1982 | K822022 | SPORT SUPPORTS Ginny, Inc. | IQI |
| Jun 24, 1982 | K821704 | FRACTURE BRACING Hosmer Dorrance Corp. | IQI |
| Jun 11, 1982 | K821641 | OBTHOSES Fred Sammons, Inc. | IQI |
| Jun 11, 1982 | K821640 | ORTHOTIC FABRICATION ACCESSORIES Fred Sammons, Inc. | IQI |
| Jun 10, 1982 | K821582 | WARM'N FORM SPORTS SUPPORTS Jerome Medical | IQI |
| Mar 8, 1982 | K820469 | WARM & FORM KNEE SUPPORTS Thermo-Mold Medical Products, Inc. | IQI |
| Jul 1, 1981 | K811704 | MULTITUBULAR AIR SPLINT KIT Roger Cestac & Assoc. | IQI |
| Jun 25, 1981 | K811690 | ANKLE-FOOT CAST/SPLINT Surgical Appliance Industries, Inc. | IQI |
| Jun 12, 1981 | K811490 | FOREARM & KNEE STRAPS Fred Sammons, Inc. | IQI |
| Jun 12, 1981 | K811456 | ORTHO-FRAC KIT Orthomedics | IQI |
| May 28, 1981 | K811343 | HUMERAL FRACTURE CAST BRACE Deseret Medical, Inc. | IQI |
| Apr 29, 1981 | K811035 | PRO COMFORT TENNIS ELBOW SUPPORT/WRIST Scholl, Inc. | IQI |
| Mar 4, 1981 | K810443 | LIMB ORTHOSIS Fred Sammons, Inc. | IQI |
| Feb 12, 1981 | K810288 | AIRCAST TENNIS ARM BAND Aircast, Inc. | IQI |
| Dec 22, 1980 | K802910 | PLASTIC FRACTURE CAST BRACE KNEE JOINT Orthomedics | IQI |
| Dec 17, 1980 | K802909 | HUMERAL FRACTURE BRACE Orthomedics | IQI |
| Dec 17, 1980 | K802908 | ULNAR FRACTURE BRACE Orthomedics | IQI |
| Dec 11, 1980 | K802871 | TIBIAL FRACTURE BRACE Orthomedics | IQI |
| Sep 16, 1980 | K802104 | C-SPLINT Cutter Laboratories, Inc. | IQI |
| Aug 7, 1980 | K801788 | HUMEROUS FRACTURE BRACE, ULNA FRACTURE Hosmer Dorrance Corp. | IQI |
| Aug 7, 1980 | K801708 | BK-1520-01 ECONOMY WRIST SUPPORT, CHILD Fred Sammons, Inc. | IQI |
| Aug 7, 1980 | K801701 | BAUER & BLACK RIGID WRIST BRACE Bd Becton Dickinson Vacutainer Systems Preanalytic | IQI |
| May 2, 1980 | K800715 | OHC DYNAMIC CLUB FOOT BRACE Ipos Luneburg | IQI |
| Aug 28, 1979 | K791565 | PARAPODIUM Physico-Medical Systems Corp. | IQI |
| Jul 24, 1979 | K791267 | SECUTEX ANKLE BAND Conphar, Inc. | IQI |
| Jul 24, 1979 | K791266 | SECUTEX KNEE BAND Conphar, Inc. | IQI |
| Jul 24, 1979 | K791249 | SECUTEX WRIST BRACE Conphar, Inc. | IQI |
| Jul 24, 1979 | K791248 | SECUTE ELBOW BAND Conphar, Inc. | IQI |
| Jun 20, 1979 | K791057 | CAST BRACE COMPONENTS 3M Company | IQI |
| Jul 31, 1978 | K781206 | FOOT POSITIONER Fred Sammons, Inc. | IQI |
| Jun 30, 1978 | K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE Aircast, Inc. | IQI |
| Feb 24, 1978 | K780225 | ORTHOSISES DEVICES Biomet, Inc. | IQI |
| Jan 17, 1978 | K780053 | BRACE, TENNIS ELBOW Bd Becton Dickinson Vacutainer Systems Preanalytic | IQI |
| Sep 20, 1977 | K771676 | FOOT DROP BOOT Medical Restraints, Inc. | IQI |
| Apr 8, 1977 | K770612 | SPLINT, BOHLER Will Ross Co. | IQI |
| Jan 28, 1977 | K770167 | KNEE SEPARATOR Bel-Art Products | IQI |
| Jan 10, 1977 | K761312 | ORTHOTIC BRACING Hosmer Dorrance Corp. | IQI |
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