FDA UDI
In Commercial Distribution
🇺🇸 United States
TensCare
DI: 05033435000739
·
Model: iSock Large
·
TENSCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TensCare
- Primary DI
- 05033435000739
- Version / Model
- iSock Large
- Catalog Number
- K-SK-L
- Company Name
- TENSCARE LIMITED
- Labeler DUNS
- 569403736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-31
- Public Version
- 1
- Public Version Date
- 2023-09-08
- Public Version Status
- New
- Public Device Record Key
- 10027cb6-95db-4d86-964f-6ac7806507f2
Device Description
The iSock Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your feet, with an intended use for the desired success of any stimulation (TENS or EMS). it is intended for a single user.
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
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05033435000739 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171721 | 000 |