Aircast Pneumatic Knee Brace
FDA 510(k) K812094 · Aircast, Inc.
510(k) numberK812094
Submission
- Device name
- Aircast Pneumatic Knee Brace
- Applicant
- Aircast, Inc.
Mchenry, IL, US - Received
- July 24, 1981
- Decision date
- August 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITQ – Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ITQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823658 | Deluxe Knee Immobilizer(Universal)ITQ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | Surgical Appliance Industries, Inc. | 06/25/1981SE |
| K810222 | Limb OrhtosisITQ · Traditional | Medical Design & Manufacturing Corp. | 02/04/1981SE |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
More from Hosmer Dorrance Corp.
| 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 |
| K810288 | Aircast Tennis Arm BandIQI · Traditional | 02/12/1981SE |
| K780979 | Airstirrup Pneumatic Ankle BraceIQI · Traditional | 06/30/1978SE |
Questions and answers
When was Aircast Pneumatic Knee Brace cleared by the FDA?
Aircast Pneumatic Knee Brace (K812094) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 20 days after the submission was received.
What is the product code of K812094?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.