Aircast Tennis Arm Band
FDA 510(k) K810288 · Aircast, Inc.
510(k) numberK810288
Submission
- Device name
- Aircast Tennis Arm Band
- Applicant
- Aircast, Inc.
Mchenry, IL, US - Received
- February 2, 1981
- Decision date
- February 12, 1981
- 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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| 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 |
| K780979 | Airstirrup Pneumatic Ankle BraceIQI · Traditional | 06/30/1978SE |
Questions and answers
When was Aircast Tennis Arm Band cleared by the FDA?
Aircast Tennis Arm Band (K810288) received a 510(k) decision of Substantially Equivalent on February 12, 1981, 10 days after the submission was received.
What is the product code of K810288?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.