FDA UDI
In Commercial Distribution
🇺🇸 United States
Digital Therapist
DI: 05065013876009
·
Model: 2
·
SWORD HEALTH, S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Digital Therapist
- Primary DI
- 05065013876009
- Version / Model
- 2
- Company Name
- SWORD HEALTH, S.A.
- Labeler DUNS
- 338007105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-07
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 8a7c5d60-fcec-4202-af92-84e7871f6b79
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60926 | Virtual-display rehabilitation system, non-supportive, home-use | An assembly of devices intended to be used both in a home and clinical setting and to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back, trunk, and/or limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., patient-worn infrared (IR) glove, motion tracking heel pad or camera, software] that communicate to provide a virtual-display interface. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065013876009 | GS1 |