Identity
- Trade Name
- PainShield Plus 3.0 Driver FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and depth of approximately 3 cm. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and depth of approximately 3 cm. FDA UDI
Identifiers
- Catalog Number
- 10-800-0006 FDA UDI
- Primary DI / UDI-DI
- 07290103422035 FDA UDI
- FDA Product Code
- PFW FDA UDI
- GMDN Term
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5300 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
MR Unsafe FDA UDI
Category: Physical therapy ultrasound/neuromuscular stimulation system
PainShield Plus 3.0 Driver by Nanovibronix Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy ultrasound/neuromuscular stimulation system.
- PowerDot — ZMI Electronics Ltd. · Class II
- Ultratone — ULTRATONE SCIENTIFIC INSTRUMENTS LIMITED · Class II
- CHATTANOOGA — DJO, LLC · Class II
- CS6101-3 Interferential Stimulator — Control Solutions, Inc. · Class II
- Johari Digital Healthcare Limited — SYRMA JOHARI MEDTECH LIMITED · Class II
- Sonicator Plus 992, 2 channel — METTLER ELECTRONICS CORP. · Class II
- Sonicator Plus 940, 4 channel — METTLER ELECTRONICS CORP. · Class II
- PROFILE EMS — Body Clock Health Care, Ltd. · 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
- Nanovibronix Inc.
Sources (1)
- FDA UDI a906462c-0cc5-4ffa-b98f-a78962b2a2a8 36 fields · synced Jun 8, 2026