Identity
- Trade Name
- PainShield 3.0 Driver FDA UDI
- Generic Name
- Physical therapy ultrasound/neuromuscular stimulation system FDA UDI
- Device Name
- PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves, and a portable battery-operated driver. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves, and a portable battery-operated driver. FDA UDI
Identifiers
- Catalog Number
- 10-800-0002 FDA UDI
- Primary DI / UDI-DI
- 07290103422028 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 3.0 Driver by Nanovibronix Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 07a6151a-2a32-4cfe-8edd-4c5f62f3fa0f 36 fields · synced May 30, 2026