FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INCARE HOT/ICE SYSTEM SHOULDER BLANKET
K Number: K964057
·
Decision Dec 31, 1996
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
92
Applicant Total
85
Review Days
83
Basic Information
- Device Name
- INCARE HOT/ICE SYSTEM SHOULDER BLANKET
- K Number
- K964057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOLLISTER, INC.
- Date Received
- October 9, 1996
- Decision Date
- December 31, 1996
- 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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