FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONAFON, THERAPEUTIC MASSAGER
K Number: K870972
·
Decision Apr 13, 1987
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
2
Review Days
35
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Basic Information
- Device Name
- SONAFON, THERAPEUTIC MASSAGER
- K Number
- K870972
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Electro Medica Office
- Date Received
- March 9, 1987
- Decision Date
- April 13, 1987
- Product Code
- IRO
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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Other Clearances by Electro Medica Office
| K Number | Device Name | ||
|---|---|---|---|
| K813569 | EMOTENS | Feb 24, 1982 | Substantially Equivalent |