Identity
- Trade Name
- ES-160 FDA UDI
- Generic Name
- Acupuncture electrical stimulation system FDA UDI
- Device Name
- Electro Stimulator Therapy Unit FDA UDI
- Model / Reference
- ES-160 FDA UDI
- Description
- Electro Stimulator Therapy Unit FDA UDI
Identifiers
- Catalog Number
- ES-160 FDA UDI
- Primary DI / UDI-DI
- 04983087008496 FDA UDI
- 510(k) Number
- K051020 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Acupuncture electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
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-160 by Ito Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupuncture electrical stimulation system.
- OSITO — Shenzhen Osto Technology Co., Ltd. · Class II
- NSS MFS — KEY ELECTRONICS, INC. · U
- Goyibam — Shenzhen Osto Technology Co., Ltd. · Class II
- Allwolf — Shenzhen Osto Technology Co., Ltd. · Class II
- NEUMONA — DYANSYS INDIA PRIVATE LIMITED · Class II
- NSS Neurostim — KEY ELECTRONICS, INC. · U
- Be-Younger — Shenzhen Osto Technology Co., Ltd. · Class II
- Creliver — Shenzhen Osto Technology Co., Ltd. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ito Co., Ltd.
Sources (1)
- FDA UDI 947bf6ee-f48b-4ed2-a4aa-a2d9d9404727 35 fields · synced May 30, 2026