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REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
REMI-Cloud
Epitel, Inc.
2.3
Not in Commercial Distribution
- 00860005388158 ()
- Bioelectrical signal analysis software
REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x
Epitel, Inc.
2.3.0
In Commercial Distribution
- 00860005388110 ()
- Bioelectrical signal analysis software
Regulora® is prescription-only digital therapeutic (PDT) software indicated for use in the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). The Regulora program is Software as a Medical Device (SaMD) that resides on and is accessed through the user’s mobile device and can be executed at home. Regulora digitizes scripted therapist-administered gut-directed psychotherapy and provides 7 unique treatment sessions, each lasting ~30 minutes, every other week over 12 weeks. The treatment sessions are designed to first induce deep physical and autonomic relaxation which is followed by metaphorical storytelling and a combination of direct and indirect suggestions targeted at somatic control mechanisms. Regulora also provides for IBS symptom tracking, which patients can share with their doctor in the management of their IBS.
Metame Health, Inc.
GDH-1
In Commercial Distribution
- 00860005970209 ()
60005-97020
- Mindfulness/behavioural therapy software, non-clinician-consultative
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution
- 00860005068319 ()
- Tone audiometer
No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution
- 00860005068302 ()
- Tone audiometer
Salux™ Tablet-Controlled Bluetooth Audiometer - The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux Audiometric solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-02
SALUX-AU-02
- Tone audiometer
20GA X 10CM (Breast Localization Needle With Two Wires)
MANAN MEDICAL PRODUCTS, INC.
KOP2010
In Commercial Distribution
- 20859013006066 ()
- 10859013006069 ()
- 00859013006062 ()
- Length: 10 Centimeter
KOP2010
- Mammographic stereotactic biopsy system
20GA X 7CM (Breast Localization Needle With Two Wires)
MANAN MEDICAL PRODUCTS, INC.
KOP2007
In Commercial Distribution
- 20859013006059 ()
- 10859013006052 ()
- 00859013006055 ()
- Length: 7 Centimeter
KOP2007
- Mammographic stereotactic biopsy system
20 GA X 5 CM Breast Localization Needle With Two Wires
MANAN MEDICAL PRODUCTS, INC.
KOP2005
In Commercial Distribution
- 20859013006028 ()
- 10859013006021 ()
- 00859013006024 ()
- Length: 5 Centimeter
KOP2005
- Mammographic stereotactic biopsy system