Identity
- Trade Name
- LiteWalk Sandals FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, arch, metatarsals and toes. These chambers inflate sequentially to mimic the sequence of walking. The large size is in : US 9-11, EU 43-45. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use. FDA UDI
- Model / Reference
- Large FDA UDI
- Description
- The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, arch, metatarsals and toes. These chambers inflate sequentially to mimic the sequence of walking. The large size is in : US 9-11, EU 43-45. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use. FDA UDI
Identifiers
- Catalog Number
- PVC0268-L FDA UDI
- Primary DI / UDI-DI
- 07290016880267 FDA UDI
- 510(k) Number
- K192607 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Sequential venous compression system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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
No
FDA UDI
Over-the-Counter
Yes
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
LiteWalk Sandals by Viasonix Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 b94be874-5db6-4df6-af38-45fe603466ef 36 fields · synced May 30, 2026