510(k) K952041

BODYFLEX MASSAGER by Truro'S Ent. — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type