FDA UDI
In Commercial Distribution
🇺🇸 United States
F-Scan Lite VersaTek
DI: B970FVL10
·
Model: F-Scan Lite VersaTek System
·
Tekscan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- F-Scan Lite VersaTek
- Primary DI
- B970FVL10
- Version / Model
- F-Scan Lite VersaTek System
- Catalog Number
- FVL1
- Company Name
- Tekscan, Inc.
- Labeler DUNS
- 178180246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-03
- Public Version
- 2
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- 70112c96-67fd-463d-a0b2-7b9c602efa08
Device Description
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File and PDF of System Manual, 6 F-Scan 3000E Sensors, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Web-Based Training Session.
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
- 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 |
|---|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | Physical Medicine | 890.1600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43829 | Body-surface pressure mapping system | An assembly of electronic devices intended to be used to measure the contact pressure between the body surface and a pressure-sensing pad to provide a map of compression forces during planning of/preparation for personal mobility device use or body support device use by a patient. Described as pressure mapping technology (PMT), it includes a sensor pad and a dedicated computer/software for data analysis, and is typically used to customize the shape of a wheelchair seating cushion to reduce the risk of pressure sore development. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B970FVL10 | HIBCC |