Identity
- Trade Name
- PainShield Plus Actuator FDA UDI
- Generic Name
- Physical therapy ultrasound system applicator, adhesive FDA UDI
- Device Name
- PainShield Plus Actuator is part of the PainShield Plus system. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- PainShield Plus Actuator is part of the PainShield Plus system. FDA UDI
Identifiers
- Catalog Number
- 10-600-0007 FDA UDI
- Primary DI / UDI-DI
- 07290103421328 FDA UDI
- FDA Product Code
- PFW FDA UDI
- GMDN Term
- Physical therapy ultrasound system applicator, adhesive 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Physical therapy ultrasound system applicator, adhesive
PainShield Plus Actuator by Nanovibronix Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy ultrasound system applicator, adhesive.
- PainShield 3.0 Actuator — NANOVIBRONIX INC. · Class II
- PainShield Patch — NANOVIBRONIX INC. · 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 |
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Manufacturer
- Manufacturer
- Nanovibronix Inc.
Sources (1)
- FDA UDI 4fc04133-2a6a-4075-b535-a5c6b7670e7f 36 fields · synced May 30, 2026