FDA UDI
In Commercial Distribution
🇺🇸 United States
iSelfCare
DI: 00147753462508
·
Model: TENS
·
Hong Qiangxing (Shen Zhen) Electronics Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
45
Basic Information
- Brand Name
- iSelfCare
- Primary DI
- 00147753462508
- Version / Model
- TENS
- Company Name
- Hong Qiangxing (Shen Zhen) Electronics Limited
- Labeler DUNS
- 421286946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 45
- Record Status
- Published
- Publish Date
- 2016-10-25
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 42936fff-ac83-4c3e-a6d4-2c8f2bf8dd73
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 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 | 00147753462508 | GS1 | ||||
| Unit of Use | 00147753462509 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121719 | 000 |