FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
MANUAL MASSAGE ROLLER
K Number: K936312
·
Decision Jan 29, 1996
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
12
Applicant Total
3
Review Days
794
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Basic Information
- Device Name
- MANUAL MASSAGE ROLLER
- K Number
- K936312
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Mckenna & Cuneo
- Date Received
- November 26, 1993
- Decision Date
- January 29, 1996
- Product Code
- LYG
- 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 |
|---|---|---|---|
| LYG | Massager, Therapeutic, Manual | FDA class 1 | Physical Medicine |
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