Identity
- Trade Name
- PainShield MD Supplies Kit FDA UDI
- Generic Name
- Physical therapy ultrasound system FDA UDI
- Device Name
- The Supplies kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable. The transducer is applied to the patient skin using single use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- The Supplies kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable. The transducer is applied to the patient skin using single use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves. FDA UDI
Identifiers
- Catalog Number
- 10-100-0013 FDA UDI
- Primary DI / UDI-DI
- 07290103421168 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Physical therapy ultrasound system
PainShield MD Supplies 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 7fad6d82-8c74-4092-afec-1537b94cb031 35 fields · synced May 31, 2026