Identity
- Trade Name
- Toe Clip PPG Sensor FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- The Toe Clip PPG sensor is designed in shape as a clothespin, primarily to fit comfortably to the toes. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI
- Model / Reference
- Toe Clip PPG Sensor FDA UDI
- Description
- The Toe Clip PPG sensor is designed in shape as a clothespin, primarily to fit comfortably to the toes. It measures the photoplethysmograph signals as a reference of blood flow for evaluation of segmental blood pressures or other peripheral vascular diagnosis tests FDA UDI
Identifiers
- Catalog Number
- PVC0143 FDA UDI
- Primary DI / UDI-DI
- 07290016880168 FDA UDI
- 510(k) Number
- K111416 FDA UDI
- FDA Product Code
- JOP FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2880 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Toe Clip PPG Sensor by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111416 also covers:
- 4 MHz probe — VIASONIX LTD
- 8 MHz probe — VIASONIX LTD
- Pressure Cuff Size 1.6 — VIASONIX LTD
- Pressure Cuff Size 1.9 — VIASONIX LTD
- Pressure Cuff Size 10 — VIASONIX LTD
- Pressure Cuff Size 12 — VIASONIX LTD
- Pressure Cuff Size 12L — VIASONIX LTD
- Pressure Cuff Size 2.5 — VIASONIX LTD
- Pressure Cuff Size 7 — VIASONIX LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Viasonix Ltd
Sources (1)
- FDA UDI 86dda0e8-c18f-4138-9a15-9816224d513a 36 fields · synced May 30, 2026