FDA.reportPublic FDA data

Bio Protech

Primary DI
00817120020579
Brand
Bio Protech
Company
BIO PROTECH USA, INC.
Model
MaxIF 1k Unit
Device description
MaxIF 1k Unit- Interferential Analog Unit
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIHInterferential Current TherapyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100246000MAX-IF1000Bio Protech, Inc.2010-11-24LIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120020576PackageGS15In Commercial Distribution
20817120020573PackageGS14In Commercial Distribution
00817120020579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002057610817120020576
2081712002057320817120020573
00817120020579008171200205798171200205790817120020579

GMDN Terms#

Term, Definition table
TermDefinition
Interferential electrical stimulation systemAn electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.

Contacts#

Phone, Email table
PhoneEmail
714-730-9950bioprotechusa@gmail.com

Regulatory Flags#

DUNS number
789127011
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120021125Bio ProtechMF2409 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01
00817120020036Bio Protech MaxTens 2k 2016-06-16
00817120021132Bio ProtechDEEG-A-10 (Lifelines)2017-08-09
00817120021149Bio ProtechDEEG-A-12 (Lifelines)2017-08-09
00817120021156Bio ProtechDEEG-A-15 (Lifelines)2017-08-09
00817120021163Bio ProtechDEEG-A-20 (Lifelines)2017-08-09
00817120021170Bio ProtechRGEEG-05 (Lifelines)2017-08-09
00817120021187Bio ProtechRGEEG-10 (Lifelines)2017-08-09
00817120021194Bio ProtechRGEEG-12 (Lifelines)2017-08-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00858563006256MAX-IFBIOPROTECH INC.LIH2025-10-13
00860012519507CPS-2000SURGITECH, INC.LIH2025-03-31
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
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08032625829812GLOBUSDOMINO SRLLIH2024-10-17
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