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510(k) K024377

TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 by Kalaco Scientific, Inc. — Product Code QJQ

K024377 is an FDA 510(k) premarket notification submitted by Kalaco Scientific, Inc. for the device "TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1". The FDA issued a decision of Substantially Equivalent on July 21, 2003. The device falls under product code QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety), a Class II device regulated under 21 CFR 882.5800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2003
Date Received
December 31, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device Class
Class II
Regulation Number
882.5800
Review Panel
NE
Submission Type

To provide electrical current to the head to treat insomnia and/or anxiety

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  • K070412 — ELEXOMA MEDIC (May 21, 2008)
  • K062284 — CES ULTRA (April 5, 2007)
  • K060158 — NET-2000 MICROCURRENT STIMULATOR (October 13, 2006)
  • K932050 — NH-2002 (June 5, 1995)
  • K910616 — LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR (May 12, 1992)

FDA data resources