510(k) K990445

LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR by Lpg USA, Inc. — Product Code ISA

K990445 is an FDA 510(k) premarket notification submitted by Lpg USA, Inc. for the device "LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR". The FDA issued a decision of Substantially Equivalent on January 18, 2000. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2000
Date Received
February 10, 1999
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