FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HITACHI HAND HELD MASSAGER A/C POWERED
K Number: K864088
·
Decision Nov 3, 1986
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
2
Review Days
13
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Basic Information
- Device Name
- HITACHI HAND HELD MASSAGER A/C POWERED
- K Number
- K864088
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Hitachi Sales Corporation of America
- Date Received
- October 21, 1986
- Decision Date
- November 3, 1986
- Product Code
- ISA
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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Other Clearances by Hitachi Sales Corporation of America
| K Number | Device Name | ||
|---|---|---|---|
| K864089 | HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA | Nov 7, 1986 | Substantially Equivalent |