Airstirrup Pneumatic Ankle Brace
FDA 510(k) K780979 · Aircast, Inc.
510(k) numberK780979
Submission
- Device name
- Airstirrup Pneumatic Ankle Brace
- Applicant
- Aircast, Inc.
Mchenry, IL, US - Received
- June 9, 1978
- Decision date
- June 30, 1978
- 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
Other 510(k)s with product code IQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143458 | NeurosplintIQI · Traditional | Neurospectrum, LLC | 08/13/2015SE |
| 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 |
|---|---|---|
| K024019 | Arterialflow System, Model 32AJOW · Traditional | 06/03/2003SE |
| K023800 | Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017JOW · Traditional | 02/10/2003SE |
| K992454 | Venaflow System, Model 30AJOW · Traditional | 01/13/2000SE |
| K964238 | Aircast Vena Flow Sterile Disposable CuffsJOW · Traditional | 09/08/1997SE |
| K961676 | Aircast Venaflow System (Modification)JOW · Traditional | 03/28/1997SE |
| K933977 | Aircast Edemaflow SystemJOW · Traditional | 12/07/1993SE |
| K932900 | Aircast Venaflow SystemJOW · Traditional | 10/25/1993SE |
| K925677 | Autochill Accessory KitILO · Traditional | 04/14/1993SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | 08/13/1981SE |
| K810288 | Aircast Tennis Arm BandIQI · Traditional | 02/12/1981SE |
Questions and answers
When was Airstirrup Pneumatic Ankle Brace cleared by the FDA?
Airstirrup Pneumatic Ankle Brace (K780979) received a 510(k) decision of Substantially Equivalent on June 30, 1978, 21 days after the submission was received.
What is the product code of K780979?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.