AccessGUDID - DEVICE: Stanza (00860010446317)

GUDID

Device Identifier (DI) Information

Brand Name: Stanza
Version or Model: 1.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Swing Therapeutics, Inc.

Primary DI Number: 00860010446317
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2033
Device Count: 1
Labeler D-U-N-S® Number*: 117470599 *Terms of Use

Device Description: A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to build their skills in acceptance and commitment therapy.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63031	Mental health/function therapeutic software, screen-viewed	A 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) 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 indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QWI	Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220083	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b484c31-2b5d-467c-889a-237f15589347
Public Version Date: August 03, 2023
Public Version Number: 2
DI Record Publish Date: July 12, 2023