510(k) K940582

MASSAGING HELMET C.F. HANSEN DESIGN by Philco Ushuaia — Product Code IRO

Clearance Details

Decision
SN ()
Decision Date
January 30, 1995
Date Received
February 8, 1994
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