RESPeRATE

Primary DI
07290017402017
Brand
RESPeRATE
Company
2BREATHE TECHNOLOGIES LTD
Model
Deluxe
Device description
RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pressure. RESPeRATE does so by harnessing the therapeutic power of slow-paced breathing with prolonged exhalation in a way that is virtually impossible to achieve on your own. All you have to do is breathe along with RESPeRATE’s guiding tones.
Published
2017-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020399000RESPERATE; MODEL RR-150Intercure , Ltd.2002-07-02HCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017402017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017402017072900174020177290017402017

GMDN Terms#

Term, Definition table
TermDefinition
Biofeedback systemAn assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600025387
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017402000RESPeRATEULTRA2017-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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