Identity
- Trade Name
- HYDRA TOUCH H2 FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which is using hydrogen water and chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Medium and low frequency radiofrequency (Y-type, Multi-type, and Electrozyme) stimulate muscle relaxation and hormone secretion for pain relief. FDA UDI
- Model / Reference
- ESK-2253HH FDA UDI
- Description
- Hydra touch H2 is equipped with two functions. First, the ‘Aqua cleansing’ which is using hydrogen water and chemical peel to help clear skin pores and eliminating hazardous wastes. Secondly, Medium and low frequency radiofrequency (Y-type, Multi-type, and Electrozyme) stimulate muscle relaxation and hormone secretion for pain relief. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800060501651 FDA UDI
- FDA Product Code
- GFE FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Hydra Touch H2 by Eunsung Global Corp — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Eunsung Global Corp
Sources (1)
- FDA UDI f445ff5b-2099-4efa-a524-3fc52fcda9c7 33 fields · synced Jun 8, 2026