FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇨🇦 Canada
MASSAGING HELMET C.F. HANSEN DESIGN
K Number: K940582
·
Decision Jan 30, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
1
Review Days
356
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Basic Information
- Device Name
- MASSAGING HELMET C.F. HANSEN DESIGN
- K Number
- K940582
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Philco Ushuaia
- Date Received
- February 8, 1994
- Decision Date
- January 30, 1995
- 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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