FDA.reportPublic FDA data

Alpha-Stim AID

Primary DI
00857869005260
Brand
Alpha-Stim AID
Company
Electromedical Products International, Inc.
Model
AID
Catalog number
500KITUS
Device description
Alpha-Stim AID kit - US
Published
2015-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or AnxietyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903014000ALPHA-STIM CSElectromedical Products, Inc.1992-05-12QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857869005260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857869005260008578690052608578690052600857869005260

GMDN Terms#

Term, Definition table
TermDefinition
Psychiatric-therapy periauricular nerve transcutaneous electrical stimulatorA portable, battery-powered device designed to apply noninvasive cranial electrical stimulation (CES) via cranial/peripheral nerves around the external ear for the treatment of psychiatric and stress-related disorders such as anxiety, depression, and insomnia. It consists of an external pulse generator (EPG) with controls/display, and transcutaneous electrodes for placement on the skin surface around the external ear (e.g., the area below the ear, ear lobe, tragus). The device may be used in conjunction with a smartphone by a patient or healthcare provider in the home and healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
610954729
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857869005000Alpha-Stim MM400KIT2014-08-25
00857869005017Alpha-Stim AIDAID500KIT2014-08-25
00857869005253Alpha-Stim MM400KITUS2015-11-30
00857869005277Alpha-Stim Conducting SolutionSL502021-11-30
00857869005284Alpha-Stim Conducting SolutionSL2502021-11-30
00857869005208Alpha-Stim SCSSCS2014-10-28
00857869005055AS-TrodesAT72014-08-25
00857869005093Alpha-Stim Earclip Electrode (CE3)Earclip Electrode (CE3)2014-08-25
00857869005130Alpha-Stim Earclip Electrode (AID)Earclip Electrode (AID)2014-08-25
00857869005147Alpha-Stim Earclip Electrode (M)Earclip Electrode (M)2014-08-25
00857869005161Alpha-Stim Earclip Electrode (M)Earclip Electrode (M) [RoHS]2014-08-29
00857869005178Alpha-Stim Earclip Electrode (AID)Earclip Electrode (AID) [RoHS]2014-08-29
00857869005215TruDenta ElectrodesTruDenta Electrodes2015-06-30
00857869005185Alpha-Stim PPMPPM2014-10-13
00857869005192Alpha-Stim 1001002014-10-28
00857869005222TruDenta MM2015-06-30
00857869005079Alpha Conducting SolutionACS2014-08-25
00857869005086Alpha Conducting Solution ACSR2014-08-25
00857869005024Alpha-Stim Probe Electrode PadPEP2014-08-25
00857869005031Alpha-Stim Earclip Electrode PadEEP2014-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M750AR635A2Calm UltraNEURO-FITNESS LLCQJQ2026-05-21
00860010064634GenesisNeurofield, Inc.QJQ2026-05-07
05070002841210Modius CalmNEUROVALENS LIMITEDQJQ2025-04-04
05070002841203Modius SleepNEUROVALENS LIMITEDQJQ2025-01-23
08908008085383Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2020-10-30
08908008085314Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
089080080853217E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2019-04-30
M750AR635A0CES-UltraNEURO-FITNESS LLCQJQ2017-06-30
M750AR635A1CES-UltraNEURO-FITNESS LLCQJQ2017-02-12
08908008085086Solace Lifesciences, IncSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
089080080852087E WellnessSYRMA JOHARI MEDTECH LIMITEDQJQ2016-09-19
00857869005253Alpha-Stim MElectromedical Products International, Inc.QJQ2015-11-30
00857869005000Alpha-Stim MElectromedical Products International, Inc.QJQ2014-08-25
00857869005017Alpha-Stim AIDElectromedical Products International, Inc.QJQ2014-08-25