FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOCHILL ACCESSORY KIT
K Number: K925677
·
Decision Apr 14, 1993
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
92
Applicant Total
11
Review Days
272
Basic Information
- Device Name
- AUTOCHILL ACCESSORY KIT
- K Number
- K925677
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AIRCAST, INC.
- Date Received
- July 16, 1992
- Decision Date
- April 14, 1993
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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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 |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aug 13, 1981 | Substantially Equivalent |
| K810288 | AIRCAST TENNIS ARM BAND | Feb 12, 1981 | Substantially Equivalent |
| K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE | Jun 30, 1978 | Substantially Equivalent |