510(k) K110509

EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 by Everyway Medical Instruments Co.,Ltd — Product Code LIH

K110509 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908". The FDA issued a decision of Substantially Equivalent on June 20, 2011. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Everyway Medical Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2011
Date Received
February 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type