FDA UDI
In Commercial Distribution
🇺🇸 United States
myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes
DI: G333KQX001
·
Model: MD
·
FUTURE HEALTH WORKS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- myrecovery, myrecovery App & Dashboard, myrecovery Patient Engagement & Outcomes
- Primary DI
- G333KQX001
- Version / Model
- MD
- Company Name
- FUTURE HEALTH WORKS LTD
- Labeler DUNS
- 220521982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- 8e6750bc-adec-4497-969d-e87a49bdcb85
Device Description
A clinical information system with a digital goniometer. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KQX | Goniometer, Ac-Powered | Orthopedic | 888.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33652 | Electronic goniometer/kinesiology sensor | A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G333KQX001 | HIBCC |