Identity
- Trade Name
- CapiFlo FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- A system used for the non-invasive treatment and prevention of venous disorders such as edema, DVT, and pulmonary embolism. It helps to enhance the proper circulation of blood in the extremities by mimicking the body's natural muscle contractions promoting blood flow. This product is portable and rechargeable. FDA UDI
- Model / Reference
- NS-9000 FDA UDI
- Description
- A system used for the non-invasive treatment and prevention of venous disorders such as edema, DVT, and pulmonary embolism. It helps to enhance the proper circulation of blood in the extremities by mimicking the body's natural muscle contractions promoting blood flow. This product is portable and rechargeable. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850053203008 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Intermittent venous compression system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intermittent venous compression system
CapiFlo by K&L Distributing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent venous compression system.
- AIRCAST — DJO, LLC · Class II
- Pulse Boot Set — NORMATEC INDUSTRIES, LP · Class II
- Blue Boot — NORMATEC INDUSTRIES, LP · Class II
- VenaOne, Pair of Batteries — Precision Medical Products · Class II
- Movement and Compressions System (MAC) — Recovery Force, LLC · Class II
- LX9max — DAESUNG MAREF CO., LTD. · Class II
- Pulse Carry Case — NORMATEC INDUSTRIES, LP · Class II
- Rapid Reboot Recovery Products — RAPID REBOOT RECOVERY PRODUCTS · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K&L Distributing, Inc.
Sources (1)
- FDA UDI 3e39cb73-4532-426b-b2ae-84b008fa91f9 35 fields · synced Jun 1, 2026