FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

RESPERATE; MODEL RR-150

Manufacturer

INTERCURE LTD.

Date Cleared

2002-07-02

(146 days)

Product Code

HCC

Regulation Number

882.5050

Why did this record match?

Applicant Name (Manufacturer) :

INTERCURE LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The RESPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.

Device Description

Biofeedback Device

Ask a Question

K Number

Device Name

INTERCURE LTD. RESPI-LOW

Manufacturer

INTERCURE LTD.

Date Cleared

2000-05-17

(100 days)

Product Code

HCC

Regulation Number

882.5050

Why did this record match?

Applicant Name (Manufacturer) :

INTERCURE LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1