Ultima NEO
Basic Information
- Brand Name
- Ultima NEO
- Primary DI
- 06942808281011
- Version / Model
- Ultima NEO
- Company Name
- EasyMed Instruments Co., Ltd.
- Labeler DUNS
- 526951168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-15
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- bca96ddc-e76f-4669-b843-92264aaf12be
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
| LIH | Interferential Current Therapy | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06942808281011 | GS1 |