FDA Product Code
FDA Product Code IQI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.3475
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143458 | Neurosplint | Neurospectrum, LLC | 2015-08-13 | Traditional | PDF ↗ |
| K052771 | SENSOR WALK | Otto Bock Healthcare LP | 2006-05-03 | Traditional | PDF ↗ |
| K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Surgitech, Inc. | 2003-07-31 | Traditional | PDF ↗ |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Regulatory & Marketing Services, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K910974 | MCCONNELL SHOULDER BRACE | Mcconnell Orthopedic | 1991-03-21 | Traditional | PDF ↗ |
| K874502 | GAIT-AID ORTHOPEDIC INSOLE | Gait-Aid, Inc. | 1987-11-30 | Traditional | PDF ↗ |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K831615 | DROP FOOT BRACE | Edward Dilauro, Jr. | 1983-06-15 | Traditional | PDF ↗ |
| K823812 | VARIOUS SUPPORTS AND SPLINTS | Danek Medical, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823113 | BRACE-UP ALL PURPOSE WRIST BAND | Arco Matic, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823160 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-11-10 | Traditional | PDF ↗ |
| K823114 | BRACE-UP STOCKING KNEE BRACE | Arco Matic, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822767 | UNIVERSAL DYNASPLINT | Dynasplint Systems, Inc. | 1982-10-06 | Traditional | PDF ↗ |
| K822022 | SPORT SUPPORTS | Ginny, Inc. | 1982-07-26 | Traditional | PDF ↗ |
| K821704 | FRACTURE BRACING | Hosmer Dorrance Corp. | 1982-06-24 | Traditional | PDF ↗ |
| K821641 | OBTHOSES | Fred Sammons, Inc. | 1982-06-11 | Traditional | PDF ↗ |
| K821640 | ORTHOTIC FABRICATION ACCESSORIES | Fred Sammons, Inc. | 1982-06-11 | Traditional | PDF ↗ |
| K821582 | WARM'N FORM SPORTS SUPPORTS | Jerome Medical | 1982-06-10 | Traditional | PDF ↗ |
| K820469 | WARM & FORM KNEE SUPPORTS | Thermo-Mold Medical Products, Inc. | 1982-03-08 | Traditional | PDF ↗ |
| K811704 | MULTITUBULAR AIR SPLINT KIT | Roger Cestac & Assoc. | 1981-07-01 | Traditional | PDF ↗ |
| K811690 | ANKLE-FOOT CAST/SPLINT | Surgical Appliance Industries, Inc. | 1981-06-25 | Traditional | PDF ↗ |
| K811456 | ORTHO-FRAC KIT | Orthomedics | 1981-06-12 | Traditional | PDF ↗ |
| K811490 | FOREARM & KNEE STRAPS | Fred Sammons, Inc. | 1981-06-12 | Traditional | PDF ↗ |
| K811343 | HUMERAL FRACTURE CAST BRACE | Deseret Medical, Inc. | 1981-05-28 | Traditional | PDF ↗ |
| K811035 | PRO COMFORT TENNIS ELBOW SUPPORT/WRIST | Scholl, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810443 | LIMB ORTHOSIS | Fred Sammons, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K810288 | AIRCAST TENNIS ARM BAND | Aircast, Inc. | 1981-02-12 | Traditional | PDF ↗ |
| K802910 | PLASTIC FRACTURE CAST BRACE KNEE JOINT | Orthomedics | 1980-12-22 | Traditional | PDF ↗ |
| K802909 | HUMERAL FRACTURE BRACE | Orthomedics | 1980-12-17 | Traditional | PDF ↗ |
| K802908 | ULNAR FRACTURE BRACE | Orthomedics | 1980-12-17 | Traditional | PDF ↗ |
| K802871 | TIBIAL FRACTURE BRACE | Orthomedics | 1980-12-11 | Traditional | PDF ↗ |
| K802104 | C-SPLINT | Cutter Laboratories, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801788 | HUMEROUS FRACTURE BRACE, ULNA FRACTURE | Hosmer Dorrance Corp. | 1980-08-07 | Traditional | PDF ↗ |
| K801701 | BAUER & BLACK RIGID WRIST BRACE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-08-07 | Traditional | PDF ↗ |
| K801708 | BK-1520-01 ECONOMY WRIST SUPPORT, CHILD | Fred Sammons, Inc. | 1980-08-07 | Traditional | PDF ↗ |
| K800715 | OHC DYNAMIC CLUB FOOT BRACE | Ipos Luneburg | 1980-05-02 | Traditional | PDF ↗ |
| K791565 | PARAPODIUM | Physico-Medical Systems Corp. | 1979-08-28 | Traditional | PDF ↗ |
| K791266 | SECUTEX KNEE BAND | Conphar, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791249 | SECUTEX WRIST BRACE | Conphar, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791248 | SECUTE ELBOW BAND | Conphar, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791267 | SECUTEX ANKLE BAND | Conphar, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K791057 | CAST BRACE COMPONENTS | 3M Company | 1979-06-20 | Traditional | PDF ↗ |
| K781206 | FOOT POSITIONER | Fred Sammons, Inc. | 1978-07-31 | Traditional | PDF ↗ |
| K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE | Aircast, Inc. | 1978-06-30 | Traditional | PDF ↗ |
| K780225 | ORTHOSISES DEVICES | Biomet, Inc. | 1978-02-24 | Traditional | PDF ↗ |
| K780053 | BRACE, TENNIS ELBOW | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-01-17 | Traditional | PDF ↗ |
| K771676 | FOOT DROP BOOT | Medical Restraints, Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K770612 | SPLINT, BOHLER | Will Ross Co. | 1977-04-08 | Traditional | PDF ↗ |
| K770167 | KNEE SEPARATOR | Bel-Art Products | 1977-01-28 | Traditional | PDF ↗ |
| K761312 | ORTHOTIC BRACING | Hosmer Dorrance Corp. | 1977-01-10 | Traditional | PDF ↗ |
| K760950 | DEVON KNEE STRAP | Devon Industries, Inc. | 1976-11-11 | Traditional | PDF ↗ |
| K760002 | KNEE AID | Zimmer, Inc. | 1976-07-26 | Traditional | PDF ↗ |
Product code IQI · Class I · Physical Medicine. Data: openFDA.