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Bio- Ultimate Platinum

FDA UDI

Class II (US FDA UDI)

by Micro Current Technology, Inc.

Identity

Trade Name
Bio- Ultimate Platinum FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Model / Reference
ULTRA FDA UDI

Identifiers

Primary DI / UDI-DI
00817076010877 FDA UDI
510(k) Number
K181062 FDA UDI
FDA Product Code
NFO FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve 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

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Bio- Ultimate Platinum by Micro Current Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K181062 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro Current Technology, Inc.

Sources (1)

  • FDA UDI 24b8baf0-b714-4802-a306-b38ea83ec489 33 fields · synced Jun 9, 2026