510(k) K050847

IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A by Theratech, Inc. — Product Code IPF

K050847 is an FDA 510(k) premarket notification submitted by Theratech, Inc. for the device "IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A". The FDA issued a decision of Substantially Equivalent on June 17, 2005. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Theratech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2005
Date Received
April 4, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type