Mcconnell Shoulder Brace
FDA 510(k) K910974 · Mcconnell Orthopedic
510(k) numberK910974
Submission
- Device name
- Mcconnell Shoulder Brace
- Applicant
- Mcconnell Orthopedic
Dallas, TX, US - Received
- March 7, 1991
- Decision date
- March 21, 1991
- 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 |
| 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 |
| K823160 | Rotation BootIQI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
More from Warm & Form, Orthopedic Materials
| 510(k) | Device | Decision |
|---|---|---|
| K905565 | Lateral Buttress SupportFWZ · Traditional | 02/21/1991SE |
| K905564 | Prep and Operating StandFWZ · Traditional | 02/21/1991SE |
| K885100 | Mcconnell Reamer GuideHTO · Traditional | 01/13/1989SE |
| K871840 | Mcconnell Orthopedic Ankle PositionerFWZ · Traditional | 05/26/1987SE |
| K871839 | Mcconnell Orthopedic Pelvic Caliper SupportFWZ · Traditional | 05/26/1987SE |
| K871824 | Mcconnell Orthopedic Suspension SystemFWZ · Traditional | 05/26/1987SE |
| K871823 | Mcconnell Orthopedic Tibial PositionerFWZ · Traditional | 05/26/1987SE |
| K871822 | Mcconnell Orthopedic U-Hook AssemblyFWZ · Traditional | 05/26/1987SE |
| K871821 | Mcconnell Orthopedic Posterior Body SupportFWZ · Traditional | 05/26/1987SE |
| K871820 | Mcconnell Orthopedic Anterior Torso-Arm SupportFWZ · Traditional | 05/26/1987SE |
Questions and answers
When was Mcconnell Shoulder Brace cleared by the FDA?
Mcconnell Shoulder Brace (K910974) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 14 days after the submission was received.
What is the product code of K910974?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.