FDA.reportPublic FDA data

InTouch Health

Primary DI
00868772000105
Brand
InTouch Health
Company
INTOUCH TECHNOLOGIES, INC.
Model
Vita Remote Presence System
Catalog number
20-15973
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123229000REMOTE PRESENCE SYSTEM, MODEL RP-VITAIntouch Health, Inc.2012-11-20DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868772000105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868772000105008687720001058687720001050868772000105

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic imaging telemedicine systemAn assembly of devices designed to electronically transmit digitized radiology images, e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine, ultrasound, endosocopy or CT, and consultative text to one or more remote sites (teleradiology). The information is typically transmitted through, e.g., public service transmission channels, phone lines or microwave relays. It is primarily distinguished from a picture archiving and communication system (PACS) by its storage capacity and intended use. PACS is a large storage system and file controller storing and retrieving thousands of images, whilst a teleradiology system typically has a storage capacity of fewer than 1, 000 images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
133033717
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868772000174InTouch HealthInTouch Imaging2019-03-19
00860000825818InTouch HealthInTouch Lite 4 with Boom2019-03-19
00868772000181InTouch HealthInTouch Lite 42019-03-19
00868772000112InTouch HealthVantage Remote Presence System2016-09-22
00868772000136InTouch HealthXpress Remote Presence System Version 220-143932016-12-09
00868772000143InTouch HealthLite Remote Presence System V320-133332016-12-09
00868772000150InTouch HealthLite Remote Presence System V22016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
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B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
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