Bio- Ultimate Platinum ULTRA
by Micro Current Technology, Inc.
Bio- Ultimate Platinum ULTRA is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Micro Current Technology, Inc., cleared under FDA 510(k) K181062 on 18 Jul 2018 and listed in FDA GUDID since 30 Jan 2019 (UDI-DI 00817076010877), active as of 22 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 | Number00817076010877 | Date30 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181062 | Date18 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 00817076010877
- FDA 510(k) database K181062
Across registries
- FDA 510(k) K181062 decided 18 Jul 2018 Active
- FDA GUDID UDI-DI 00817076010877 listed 30 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K181062
- Listed FDA GUDID 00817076010877
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bio- Ultimate Platinum
- Generic name
- Analgesic transcutaneous electrical nerve stimulation system
- Model / reference
- ULTRA
- Primary DI / UDI-DI
- 00817076010877
- 510(k) Number
- FDA product code
- NFO
- GMDN term
- Analgesic transcutaneous electrical nerve stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Analgesic transcutaneous electrical nerve stimulation system.