FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
K Number: K062476
·
Decision Oct 31, 2006
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
65
Applicant Total
3
Review Days
68
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Basic Information
- Device Name
- CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
- K Number
- K062476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceragem International, Inc.
- Date Received
- August 24, 2006
- Decision Date
- October 31, 2006
- Product Code
- JFB
- 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 |
|---|---|---|---|
| JFB | Table, Physical Therapy, Multi Function | FDA class 2 | Physical Medicine |
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