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510(k) K903014

ALPHA-STIM CS by Electromedical Products, Inc. — Product Code QJQ

K903014 is an FDA 510(k) premarket notification submitted by Electromedical Products, Inc. for the device "ALPHA-STIM CS". 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. Electromedical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1992
Date Received
July 10, 1990
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 Electromedical Products, Inc.

  • K896948 — ALPHA-STIM CS (February 23, 1990)
  • K881753 — ALPHA-STIM 350 (August 30, 1988)
  • K831145 — ALPHA-STIM 350 (July 7, 1983)
  • K831144 — ALPHA-STIM 2000 (June 30, 1983)

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)
  • 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