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510(k) K090052

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C by Johari Digital Healthcare , Ltd. — Product Code QJQ

K090052 is an FDA 510(k) premarket notification submitted by Johari Digital Healthcare , Ltd. for the device "CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C". The FDA issued a decision of Substantially Equivalent on May 29, 2009. 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. Johari Digital Healthcare , Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
January 7, 2009
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 Johari Digital Healthcare , Ltd.

  • K131291 — TORC BODY (June 14, 2013)
  • K112351 — ULTRA BEAUTY (March 30, 2012)
  • K102190 — WINSTIM (March 17, 2011)
  • K062439 — POWERTONE, MODEL PT-11 (January 8, 2007)
  • K060246 — INFREX (May 5, 2006)
  • K024036 — PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 (December 20, 2002)

Other clearances for product code QJQ

  • K252951 — Genesis Sleep (December 31, 2025)
  • K232253 — Modius Stress (March 27, 2024)
  • K230826 — Modius Sleep (October 27, 2023)
  • K182311 — Cervella (March 7, 2019)
  • 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)
  • K910616 — LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR (May 12, 1992)

FDA data resources