Identifiers
- 510(k) Number
- K161484 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Stimulator, Transcutaneous Electrical, Aesthetic Purposes, as defined in the nomenclature authority. It is intended for aesthetic purposes using transcutaneous electrical stimulation.
It is supplied as a home-use device, with authorization under FDA 510(k) K161484, classified as Class II, and regulated under regulation number 882.5890. The device falls under the medical specialty of Neurology and was reviewed by the Neurology advisory committee.
Frequently asked questions
What is the ZIIP Device intended for?
The ZIIP Device is intended for aesthetic purposes using transcutaneous electrical stimulation, as defined in the nomenclature authority for Stimulator, Transcutaneous Electrical, Aesthetic Purposes.
How is the ZIIP Device supplied and for what use?
The device is supplied as a home-use device, meaning it is designed for consumer use outside of a clinical setting, based on its FDA 510(k) authorization and labeling.
What regulatory pathway was used for the ZIIP Device?
The ZIIP Device received authorization through the FDA 510(k) pathway under submission K161484, with a determination of substantial equivalence to a predicate device.
What is the device classification and regulation number for the ZIIP Device?
The ZIIP Device is classified as Class II and is regulated under regulation number 882.5890, as indicated in its FDA 510(k) documentation.
Which medical specialty and advisory committee were involved in the review of the ZIIP Device?
The device falls under the medical specialty of Neurology and was reviewed by the Neurology advisory committee, as recorded in its FDA submission details.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZIIP | Expert Facials On Demand, ZIIP - amazon.com, ZIIP+ Device 510 (k) K212342 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161484 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ziip, Llc
- FDA Applicant
- Ziip,Llc
Sources (1)
- FDA 510(k) K161484 24 fields · synced Sep 21, 2026