Identity
- Trade Name
- ES-130 EUDAMEDFDA UDI
- Generic Name
- Acupuncture electrical stimulation system FDA UDI
- Device Name
- ES-130 EUDAMEDElectro Acupuncture Therapy Unit FDA UDI
- Model / Reference
- ES-130 EUDAMEDFDA UDI
- Description
- Electro Acupuncture Therapy Unit FDA UDI
Identifiers
- Catalog Number
- ES-130 FDA UDI
- Primary DI / UDI-DI
- 04983087008403 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04983087008403 EUDAMED
- 510(k) Number
- K081943 FDA UDI
- FDA Product Code
- BWK FDA UDI
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
- GMDN Term
- Acupuncture electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Cyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Acupuncture electrical stimulation system
Es-130 by Ito Co., Ltd. — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Ito Co., Ltd.
Sources (2)
- FDA UDI b5922f5f-39ea-46d8-b3f2-4463222425ad 35 fields · synced Jul 28, 2026
- EUDAMED 35bdb2da-022d-4eb1-9116-322805af6d5a 61 fields · synced Jul 28, 2026