MotionSense Knee Alignment Block
- Primary DI
- 15060808320115
- Brand
- MotionSense Knee Alignment Block
- Company
- ENMOVI LTD
- Model
- 007-00068-US
- Catalog number
- 007-00068-US
- Device description
- MotionSense Knee Alignment Block
- Published
- 2022-07-15
- 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 |
|---|
| KQX | Goniometer, Ac-Powered |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KQX | Goniometer, Ac-Powered | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 15060808320115 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 15060808320115 | 15060808320115 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Humidity | 15 Percent (%) Relative Humidity | 75 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 0 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 225424353
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 55060808320151 | MotionSense Application Version 1.4 | SW-1.4-MSAPP | SW-1.4-MSAPP | 2023-01-27 |
| 55060808320168 | MotionSense Application Version 1.5 | SW-1.5-MSAPP | SW-1.5-MSAPP | 2023-01-27 |
| 55060808320120 | OrthoLogIQ PT Version 1.0 | SW-1.0-OIQPT | SW-1.0-OIQPT | 2023-01-27 |
| 15060808320092 | MotionSense Digital Goniometer | 007-00066-US | 007-00066-US | 2022-07-15 |
| 15060808320108 | MotionSense Adhesive Refill Kit | 007-00067-US | 007-00067-US | 2022-07-15 |
| 55060808320076 | MotionSense Application Version 1.3 | SW-1.3-MSAPP | SW-1.3-MSAPP | 2022-07-15 |
| 15060808320023 | MotionSense Adhesive Refill Kit | MotionSense 2.0 | 007-00037-US | 2021-08-13 |
| 15060808320030 | MotionSense Knee Alignment Block | MotionSense 2.0 | 007-00038-US | 2021-08-13 |
| 55060808320007 | MotionSense Digital Goniometer | MotionSense 2.0 | 007-00036-US | 2021-08-13 |
Other Devices Sharing Product Codes