nfant® Thrive Feeding System

Primary DI
00196852268917
Brand
nfant® Thrive Feeding System
Company
NFANT LABS LLC
Model
1
Catalog number
NTFS
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143507000NFANT Feeding SolutionNfant Labs, LLC2015-09-09HCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852268917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852268917001968522689171968522689170196852268917

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007617601info@nfant.com

Regulatory Flags#

DUNS number
080007197
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861410000208nfant® Patient Database1ND32016-09-23
00861410000215nfant® SSB Sensor1NS12016-09-23
00861410000239nfant® Coupling1NC2-12016-09-23
00861410000246nfant® Mobile App1NA42016-09-23

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Primary DI, Brand, Company table
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04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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