FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIRCAST PNEUMATIC KNEE BRACE
K Number: K812094
·
Decision Aug 13, 1981
Classifications
1
FEI Numbers
442
Registration Numbers
442
Same Product Code
14
Applicant Total
11
Review Days
20
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Basic Information
- Device Name
- AIRCAST PNEUMATIC KNEE BRACE
- K Number
- K812094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Aircast, Inc.
- Date Received
- July 24, 1981
- Decision Date
- August 13, 1981
- Product Code
- ITQ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITQ | Joint, Knee, External Brace | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITQ), ordered by most recent decision date.
LIMITED MOTION FUNCTIONAL KNEE BRACE
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BRACE C.T.
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DELUXE KNEE IMMOBILIZER(UNIVERSAL)
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ANATOMIC FRACTURE BRACE
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DELUXE KNEE IMMOBILIZER
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NEOPRENE KNEE SUPPORT
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Aircast, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | Jun 3, 2003 | Substantially Equivalent |
| K023800 | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 | Feb 10, 2003 | Substantially Equivalent |
| K992454 | VENAFLOW SYSTEM, MODEL 30A | Jan 13, 2000 | Substantially Equivalent |
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | Sep 8, 1997 | Substantially Equivalent |
| K961676 | AIRCAST VENAFLOW SYSTEM (MODIFICATION) | Mar 28, 1997 | Substantially Equivalent |
| K933977 | AIRCAST EDEMAFLOW SYSTEM | Dec 7, 1993 | Substantially Equivalent |
| K932900 | AIRCAST VENAFLOW SYSTEM | Oct 25, 1993 | Substantially Equivalent |
| K925677 | AUTOCHILL ACCESSORY KIT | Apr 14, 1993 | Substantially Equivalent |
| K810288 | AIRCAST TENNIS ARM BAND | Feb 12, 1981 | Substantially Equivalent |
| K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE | Jun 30, 1978 | Substantially Equivalent |