Identity
- Trade Name
- PlasmaWave FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and an LCD display provide user interface. FDA UDI
- Model / Reference
- PWAVE01 FDA UDI
- Description
- The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and an LCD display provide user interface. FDA UDI
Identifiers
- Catalog Number
- PWAVE01 FDA UDI
- Primary DI / UDI-DI
- 00810113681795 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
No
FDA UDI
Category: Intermittent venous compression system
PlasmaWave by Manamed Llc — 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
- Manamed Llc
Sources (1)
- FDA UDI 14bd3ea2-d265-48d4-83bd-a4880f7e429c 35 fields · synced May 30, 2026