FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Electronic Pain Relief Stimulator Replacement Pads
DI: 00810038634364
·
Model: ETP019
·
EASY HEALTHCARE CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Easy@Home Electronic Pain Relief Stimulator Replacement Pads
- Primary DI
- 00810038634364
- Version / Model
- ETP019
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-31
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 647b7f2b-7988-4cf0-868b-295b512651ba
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
- Yes
- 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 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis | Neurology | 882.5890 | 2 |
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45208 | Interferential electrical stimulation system electrode | A component of an interferential electrical stimulation system designed to conduct electrical currents from the system's pulse generator to specific areas of the body typically to treat pain. In interferential treatment it is typical to use two electrical conductors (electrodes) that are attached to the patient's skin at opposite corners of a square along which currents are delivered (e.g., 4000 and 41000 Hz) that interfere at its centre. This results in a beat frequency at the difference between the frequencies and this is used to treat muscle disorders or, at higher frequencies, to relieve pain. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810038634361 | GS1 | 501 | In Commercial Distribution | ||
| Primary | 00810038634364 | GS1 |