Identity
- Trade Name
- PainShield MD Kit FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- PainShield MD 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 a depth of approximately 3 cm. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- PainShield MD 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 a depth of approximately 3 cm. FDA UDI
Identifiers
- Catalog Number
- 10-100-0001 FDA UDI
- Primary DI / UDI-DI
- 07290103421236 FDA UDI
- FDA Product Code
- PFW FDA UDI
- GMDN Term
- Physical therapy ultrasound 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Physical therapy ultrasound system
PainShield MD Kit 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 20b1fef6-1ddd-487a-98a8-d38b300735dc 35 fields · synced Jun 8, 2026