FDA UDI
In Commercial Distribution
🇺🇸 United States
F-Socket Versatek
DI: B970SV10
·
Model: F-Socket VersaTek (1 Cuff) System
·
Tekscan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- F-Socket Versatek
- Primary DI
- B970SV10
- Version / Model
- F-Socket VersaTek (1 Cuff) System
- Catalog Number
- SV1
- 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
- 9a28dca2-b3be-4f18-b6ef-7745d48cfd84
Device Description
Includes 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Clinical Foot Software CD with Sensor Map, Help File and PDF of System Manual, 10 ft. USB Cable, 25 ft. Cuff Cable, Velcro Wrist/Ankle Band, Waist Belt, Sensor Carrying Case, System Carrying Case, and 1 Web-Based Training Session. System includes one of the following Sensor selections: (4) 9811E Sensors -or- (2) 9833E sensors.
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 | B970SV10 | HIBCC |