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510(k) K230826

Modius Sleep by Neurovalens , Ltd. — Product Code QJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
March 24, 2023
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)
  • 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)
  • K903014 — ALPHA-STIM CS (May 12, 1992)