FDA.reportPublic FDA data

Alpha-Stim M

Primary DI
00857869005000
Brand
Alpha-Stim M
Company
Electromedical Products International, Inc.
Model
M
Catalog number
400KIT
Device description
Alpha-Stim M kit - China
Published
2014-08-25
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or AnxietyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896948000
K903014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896948000ALPHA-STIM CSElectromedical Products, Inc.1990-02-23GZJ
K903014000ALPHA-STIM CSElectromedical Products, Inc.1992-05-12QJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857869005000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857869005000008578690050008578690050000857869005000

GMDN Terms#

Term, Definition table
TermDefinition
Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation systemA battery-powered, portable, electronic device designed to apply transcutaneous electrical stimulation to treat: 1) stress and stress-related disorders, including but not limited to anxiety, depression, and insomnia; and 2) neuromuscular symptoms (e.g., pain) and disorders typically as a form of physical therapy. It consists of a pulse generator (EPG) with separate channels for connection of a dedicated electrode/probe for each application. The device may be used in the home or in a clinical setting.

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
00857869005017Alpha-Stim AIDAID500KIT2014-08-25
00857869005253Alpha-Stim MM400KITUS2015-11-30
00857869005260Alpha-Stim AIDAID500KITUS2015-11-30
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

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