FDA UDI
In Commercial Distribution
🇺🇸 United States
Restore Skills Therapy
DI: G629RESTORESKILLSTHERA0
·
Model: 1
·
TIMOCCO USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Restore Skills Therapy
- Primary DI
- G629RESTORESKILLSTHERA0
- Version / Model
- 1
- Company Name
- TIMOCCO USA, INC.
- Labeler DUNS
- 090141480
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-27
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- b0a4b9d4-7693-435f-b8c9-dcaa7e290eea
Device Description
Interactive rehabilitation exercise device, prescription use
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QKC | Interactive Rehabilitation Exercise Device, Prescription Use | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66912 | Daily routine exercise software | A software program intended to be used on a non-medical computerized device and a display unit (e.g., television) to provide virtual exercise-based interactive activities/games for daily/regular use to help maintain or improve physical/mental health; it is not dedicated to physical rehabilitation. It may be intended for use with one or more type(s) of electronic exercise device(s) [e.g., cycle device] and may provide one or more type(s) of on-screen interaction (e.g., video of a journey). It is not intended to provide specific biomechanical function analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G629RESTORESKILLSTHERA0 | HIBCC |