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510(k) K232253

Modius Stress by Neurovalens Limited — Product Code QJQ

K232253 is an FDA 510(k) premarket notification submitted by Neurovalens Limited for the device "Modius Stress". The FDA issued a decision of Substantially Equivalent on March 27, 2024. 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. Neurovalens Limited has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2024
Date Received
July 28, 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 by Neurovalens Limited

Other clearances for product code QJQ

  • K252951 — Genesis Sleep (December 31, 2025)
  • 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)
  • K903014 — ALPHA-STIM CS (May 12, 1992)

FDA data resources