Identity
- Trade Name
- Ultima NEO FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for: • Relaxation of muscle spasm; • Increasing local blood circulation and muscle re-education; • Prevention or retardation of disuse atrophy; • Prevention of venous thrombosis of the calf muscles immediately after surgery; • Maintaining or increasing range of motion. MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain. IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for: • Symptomatic relief of chronic intractable pain. FDA UDI
- Model / Reference
- Ultima NEO FDA UDI
- Description
- TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain. EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for: • Relaxation of muscle spasm; • Increasing local blood circulation and muscle re-education; • Prevention or retardation of disuse atrophy; • Prevention of venous thrombosis of the calf muscles immediately after surgery; • Maintaining or increasing range of motion. MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain. IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for: • Symptomatic relief of chronic intractable pain. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06942808281011 FDA UDI
- FDA Product Code
- IPF FDA UDIGZJ FDA UDILIH FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Ultima NEO by EasyMed Instruments Co., Ltd. — 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
- EasyMed Instruments Co., Ltd.
Sources (1)
- FDA UDI bca96ddc-e76f-4669-b843-92264aaf12be 33 fields · synced Jun 8, 2026