510(k) K931639

F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR by Fairform Mfg., Co., Ltd. — Product Code IRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
March 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vibrator, Therapeutic
Device Class
Class I
Regulation Number
890.5975
Review Panel
PM
Submission Type