FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home TENS Pain Relief Device
DI: 00810038630113
·
Model: EHE009
·
EASY HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Easy@Home TENS Pain Relief Device
- Primary DI
- 00810038630113
- Version / Model
- EHE009
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-03
- Public Version
- 3
- Public Version Date
- 2023-05-04
- Public Version Status
- Update
- Public Device Record Key
- 1630d523-944d-4f49-9ec0-91454ebfc722
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 44743 | Static magnetic therapeutic clothing/jewelry | A body-worn magnetized metallic device intended to be used in the home to produce a weak magnetic flux field over a superficial body site to provide comfort and localized temporary relief from aches, pain or tension (e.g., due to arthritis, sciatica, whiplash, sports injuries, muscle soreness/stiffness, dysmenorrhea, menopause), psycho-emotional stress, and/or sleep ailments. It is available in a variety of forms (e.g., clothing, belt, insole, bracelet, necklace, ring, plate, disk, pad, mask) and may be attached to clothing or applied directly to the skin with an adhesive plaster. It is not designed as an orthosis (i.e. does not provide therapeutic body support). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810038630110 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00810038630113 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131921 | 000 |