FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads
DI: 00855944007659
·
Model: ETP015
·
EASY HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads
- Primary DI
- 00855944007659
- Version / Model
- ETP015
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2019-07-31
- Public Version
- 1
- Public Version Date
- 2019-08-08
- Public Version Status
- New
- Public Device Record Key
- d97d5f3f-49c4-4e6b-9db9-75dc2ae4a27c
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59689 | Neuromuscular transmission electrode | A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855944007659 | GS1 | ||||
| Package | 10855944007656 | GS1 | Carton | 30 | In Commercial Distribution | |
| Unit of Use | 90855944007652 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141260 | 000 |