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Nu Skin RenuSpa iO Package

FDA UDI

Class II (US FDA UDI)

by Nse Products, Inc.

Identity

Trade Name
Nu Skin RenuSpa iO Package FDA UDI
Generic Name
Skin topical coupling gel FDA UDI
Model / Reference
01002910 FDA UDI

Identifiers

Primary DI / UDI-DI
00850021097561 FDA UDI
510(k) Number
K022006 FDA UDI
K232001 FDA UDI
FDA Product Code
NFO FDA UDI
GYB FDA UDI
GMDN Term
Skin topical coupling gel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
882.1275 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation systemSkin topical coupling gelTranscutaneous electrical stimulation probe

Nu Skin RenuSpa iO Package by Nse Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation probe.

Cleared under the same submission

K022006 also covers:

K232001 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nse Products, Inc.

Sources (1)

  • FDA UDI 47946de5-e756-4883-aa0b-01ac5fc1b27c 33 fields · synced Jun 6, 2026