Foot Drop Boot
FDA 510(k) K771676 · Medical Restraints, Inc.
510(k) numberK771676
Submission
- Device name
- Foot Drop Boot
- Applicant
- Medical Restraints, Inc.
Mchenry, IL, US - Received
- September 2, 1977
- Decision date
- September 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQI – Orthosis, Limb Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
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| K052771 | Sensor WalkIQI · Traditional | Otto Bock Healthcare LP | 05/03/2006SE |
| K031576 | Spartan Orthopaedic Wrist Brace, Model SCT-1IQI · Traditional | Surgitech, Inc. | 07/31/2003SE |
| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | Mcconnell Orthopedic | 03/21/1991SE |
| K874502 | Gait-Aid Orthopedic InsoleIQI · Traditional | Gait-Aid, Inc. | 11/30/1987SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831615 | Drop Foot BraceIQI · Traditional | Edward Dilauro, Jr. | 06/15/1983SE |
| K823812 | Various Supports and SplintsIQI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
More from Arco Matic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K771636 | Body RestraintFMQ · Traditional | 09/30/1977SE |
| K771630 | Limb RestraintFMQ · Traditional | 09/30/1977SE |
| K771629 | Hand RestraintFMQ · Traditional | 09/30/1977SE |
| K771715 | Pelvic Wheelchair RestraintFMQ · Traditional | 09/28/1977SE |
| K771635 | Foot ElevatorFMQ · Traditional | 09/28/1977SE |
| K771634 | Vest RestraintFMQ · Traditional | 09/28/1977SE |
| K771632 | Finger Mitt RestraintFMQ · Traditional | 09/28/1977SE |
| K771633 | Heel ProtectorFMP · Traditional | 09/12/1977SE |
| K771631 | Wheelchair Safety BeltKNN · Traditional | 09/12/1977SE |
Questions and answers
When was Foot Drop Boot cleared by the FDA?
Foot Drop Boot (K771676) received a 510(k) decision of Substantially Equivalent on September 20, 1977, 18 days after the submission was received.
What is the product code of K771676?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.