FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
K Number: K041200
·
Decision Jun 17, 2004
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
65
Applicant Total
2
Review Days
41
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Basic Information
- Device Name
- THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
- K Number
- K041200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Migun Medical Instrument Co. , Ltd.
- Date Received
- May 7, 2004
- Decision Date
- June 17, 2004
- 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 |
Similar 510(k) Clearances
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Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
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Other Clearances by Migun Medical Instrument Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032449 | THERMASSAGE ENERGY PRODUCT, MODEL HY5000 | Oct 22, 2003 | Substantially Equivalent |