Es-160
Es-160 is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K051020 on 24 Feb 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04983087008496), active as of 21 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04983087008496 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051020 | Date24 Feb 2006 | StatusActive |
Official records
- AccessGUDID record 04983087008496
- FDA 510(k) database K051020
Across registries
- FDA 510(k) K051020 decided 24 Feb 2006 Active
- FDA GUDID UDI-DI 04983087008496 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051020
- Listed FDA GUDID 04983087008496
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Acupuncture electrical stimulation system
- Model / Ref / Catalog
- ES-160
- Primary DI / UDI-DI
- 04983087008496
- 510(k) Number
- FDA product code
- GZJ
- GMDN term
- Acupuncture electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
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