FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
SHIATSU MASSAGER
K Number: K942218
·
Decision Jun 22, 1994
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
2
Review Days
47
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Basic Information
- Device Name
- SHIATSU MASSAGER
- K Number
- K942218
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Westminster International Co., Inc.
- Date Received
- May 6, 1994
- Decision Date
- June 22, 1994
- 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 Westminster International Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940621 | PRO-SHIATSU PORTABLE MASSAGER | Jun 22, 1994 | Substantially Equivalent for Some Indications |