Stanza

Primary DI
07290016986235
Brand
Stanza
Company
XR HEALTH IL LTD
Model
CORE
Device description
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment offibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance andcommitment therapy.
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia SymptomsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220083000StanzaSwing Therapeutics, Inc.2023-05-09QWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016986235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016986235072900169862357290016986235

GMDN Terms#

Term, Definition table
TermDefinition
Mental health/function therapeutic software, screen-viewedA screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading, speech) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically track development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient and may involve clinical assistance/recommendations.

Contacts#

Phone, Email table
PhoneEmail
+1 (857) 990-6111Support@xr.health

Regulatory Flags#

DUNS number
531893653
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016986228StanzaREIN2026-07-27
07290016986211XRBehaviorVRSO-940 (Step Out)2026-05-14
07290016986204XRBehaviorVRGC-940 (GameChange)2026-05-04
07290016986198XRCogni CT-630 Koji Quest2026-02-12
07290016986174XRBehaviorVRMM-920 (Mind&Motion)2026-01-26
07290016986181XRBehaviorVRFR-930 (First Resort)2026-01-26
07290016986143VRCBTAT-910 (A10tion)VRCBT AT-9102021-06-15
07290016986129VRRelieverMD-710 (Relax8)2020-01-21
07290016986112VRCogniCT-620 (Memorize)2019-12-30
07290016986105VRCogniCT-610 (Re-Act)2019-11-28
07290016986068VRRelieverCB-510 (Luna)2019-06-13
07290016986167VRBehaviorVRET-910 (Expose)2024-04-09
07290016986075VRCogniMC-320 (Color Match)2020-02-20
07290016986099VRPhysio N-140 (Rotate)2019-10-16
07290016986082VRPhysio MT-220 (Balloon Blast)2019-09-08
07290016986006VRPhysioN-110 (Aqua Clown)2018-05-01
07290016986013VRPhysioMT-210 (Balloon Blast)2018-05-01
07290016986020VRPhysioN-120 (Catch the Screen)2018-05-01
07290016986037VRPhysioP-410 (Dot Track)2018-07-18
07290016986044VRPhysioMC-310 (Color Match)2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016986228StanzaXR HEALTH IL LTDQWI2026-07-27
00860010446355StanzaSwing Therapeutics, Inc.QWI2025-09-15
00860010446362StanzaSwing Therapeutics, Inc.QWI2025-09-15
00860010446324StanzaSwing Therapeutics, Inc.QWI2023-07-13
00860010446317StanzaSwing Therapeutics, Inc.QWI2023-07-12