FDA UDI
In Commercial Distribution
🇺🇸 United States
SERIES-5 MyoVision Full System
DI: 00853818007422
·
Model: D2-D5-D6-D7L
·
PRECISION BIOMETRICS INC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SERIES-5 MyoVision Full System
- Primary DI
- 00853818007422
- Version / Model
- D2-D5-D6-D7L
- Catalog Number
- D2-D5-D6-D7L
- Company Name
- PRECISION BIOMETRICS INC
- Labeler DUNS
- 362997926
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-28
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- 852fe694-b496-4b7d-9a70-28660f4b4548
Device Description
VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
| HCS | Device, Temperature Measurement, Direct Contact, Powered | Neurology | 882.1570 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32521 | Multiple physiological signal amplifier | An electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853818007422 | GS1 |
Customer Contacts
- Phone
- 800-969-6961
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123399 | 000 |