FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
STIMULATOR, ULTRASOUND AND MUSCLE
K Number: K871647
·
Decision Jun 29, 1987
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
1
Review Days
62
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Basic Information
- Device Name
- STIMULATOR, ULTRASOUND AND MUSCLE
- K Number
- K871647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Amy West
- Date Received
- April 28, 1987
- Decision Date
- June 29, 1987
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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