FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONIX...THERAPEUTIC SONIC MASSAGE
K Number: K913439
·
Decision Jan 22, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
3
Review Days
173
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Basic Information
- Device Name
- SONIX...THERAPEUTIC SONIC MASSAGE
- K Number
- K913439
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mcshirley Products, Inc.
- Date Received
- August 2, 1991
- Decision Date
- January 22, 1992
- 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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