510(k) K896226

LISS BODY STIMULATOR MODEL SBL501-M by Medical Consultants Intl. , Ltd. — Product Code GZJ

K896226 is an FDA 510(k) premarket notification submitted by Medical Consultants Intl. , Ltd. for the device "LISS BODY STIMULATOR MODEL SBL501-M". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Medical Consultants Intl. , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
October 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type