Stanza
- Primary DI
- 00860010446317
- Brand
- Stanza
- Company
- Swing Therapeutics, Inc.
- Model
- 1.2
- 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.
- Published
- 2023-07-12
- 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
Product Codes
| Code | Name |
|---|
| QWI | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QWI | Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms | Neurology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN220083 | 000 | Stanza | Swing Therapeutics, Inc. | 2023-05-09 | QWI |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860010446317 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00860010446317 | 00860010446317 | 860010446317 | 0860010446317 |
GMDN Terms
| Term | Definition |
|---|
| 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, 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/clinical recommendations. |
Regulatory Flags
- DUNS number
- 117470599
- 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
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