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510(k) K910616

LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR by Life Balance Intl., Inc. — Product Code QJQ

K910616 is an FDA 510(k) premarket notification submitted by Life Balance Intl., Inc. for the device "LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR". The FDA issued a decision of Substantially Equivalent on May 12, 1992. 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
May 12, 1992
Date Received
February 12, 1991
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

Other clearances for product code QJQ

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  • K232253 — Modius Stress (March 27, 2024)
  • K230826 — Modius Sleep (October 27, 2023)
  • K182311 — Cervella (March 7, 2019)
  • K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (May 29, 2009)
  • K070412 — ELEXOMA MEDIC (May 21, 2008)
  • K062284 — CES ULTRA (April 5, 2007)
  • K060158 — NET-2000 MICROCURRENT STIMULATOR (October 13, 2006)
  • K024377 — TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (July 21, 2003)
  • K932050 — NH-2002 (June 5, 1995)

FDA data resources