FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LiteWalk Sandals
DI: 07290016880281
·
Model: Small
·
VIASONIX LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LiteWalk Sandals
- Primary DI
- 07290016880281
- Version / Model
- Small
- Catalog Number
- PVC0268-S
- Company Name
- VIASONIX LTD
- Labeler DUNS
- 533070236
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 1
- Public Version Date
- 2020-06-29
- Public Version Status
- New
- Public Device Record Key
- ade30143-ab17-4db3-bf81-5465ec4527d7
- Distribution End Date
- 2020-06-19
Device 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 Small size is in : US 3-5, EU 35-38. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | Physical Medicine | 890.5650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16837 | Sequential venous compression system | A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016880281 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192607 | 000 |