(57 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or algorithms.
No.
The device is indicated for "over-the-counter cosmetic use" for "facial and neck stimulation," which does not align with the definition of a therapeutic device designed to treat or prevent a disease or condition. Its purpose is cosmetic.
No.
The device is indicated for facial and neck stimulation for over-the-counter cosmetic use, and the description states it stimulates "superficially through application of transcutaneous electrical currents," which are stimulative, not diagnostic.
No
The device description explicitly states it is a "hand-held, battery-powered device" and mentions hardware components like a Lithium-Ion battery and charger. The performance studies also include electrical safety testing and biocompatibility evaluation, which are relevant to hardware.
Based on the provided information, the ZIIP+ Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial and neck stimulation" for "over-the-counter cosmetic use." This describes a device applied externally to the body for cosmetic purposes, not a test performed on samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description details a hand-held device that applies electrical currents to the skin. This aligns with an external stimulation device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The testing performed (electrical safety, software, biocompatibility) is consistent with a device applied externally to the body, not an IVD.
Therefore, the ZIIP+ Device is a cosmetic electrical stimulation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ZIIP+ Device is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Product codes
NFO
Device Description
The ZIIP+ Device is a hand-held, battery-powered device used with conductive gel to stimulate the face superficially through application of transcutaneous electrical currents. The device is powered by a Lithium-Ion rechargeable battery, and it is shipped with a portable battery charger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comprehensive performance testing was performed to support the substantial equivalence determination for the ZIIP+ Device, including the following:
- . Electrical Safety Testing, including EMC. Specifically, the ZIIP+ Device was tested and found to be in compliance with:
- o IEC 60601- 1 -2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – requirements and tests) for radiated and power line conducted emissions
- IEC 60601-1 (Medical electrical equipment: Part 1: General requirements for basic o safety and essential performance) for Electrical Safety
- o IEC 60601-1-11 (Medical Electrical Equipment: Part 1-11: Requirements for medical electrical systems used in the home healthcare environment) for home healthcare devices
- Software Verification and Validation Testing
- The results of software verification and validation confirmed that the ZIIP+ Device meets and complies with the applicable software requirements specifications.
- Biocompatibility Evaluation
- The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible; therefore, the ZIIP+ Device is biocompatible and substantially equivalent to the predicate device.
In summary, the safety and performance testing results for EMC, Electrical Safety, Wireless Coexistence, and Verification & Validation concluded that the ZIIP+ Device complies with the applicable standards and meets bench testing performance requirements.
- The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible; therefore, the ZIIP+ Device is biocompatible and substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K161484 ZIIP Skincare Device, K201782 NūFACE® Trinity Plus
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 23, 2021
ZIIP, Inc. % Heather Tanner Principle Consultant Hill Regulatory Consulting, LLC 1910 15th Ave E Seattle, Washington 98112
Re: K212342
Trade/Device Name: ZIIP+ Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: July 23, 2021 Received: July 28, 2021
Dear Heather Tanner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212342
Device Name ZIIP+ Device
Indications for Use (Describe)
The ZIIP+ Device is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
510(k) Notification K212342
1. GENERAL INFORMATION
Applicant: ZIIP Inc. 1425 Leimert Blvd Suite 203 Oakland, CA 94602
Contact Person: David Mason President, ZIIP, Inc. Contact information: david@ziipbeauty.com
Date Prepared: July 23, 2021
2. DEVICE INFORMATION
Trade Name: ZIIP+ Device
Generic/Common Name: Facial Toning Device
Classification: Transcutaneous Electrical Nerve Stimulatory - CFR 882.5890
Product Code: NFO
3. PREDICATE DEVICE(S)
4. INDICATIONS FOR USE
The ZIIP+ Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
5. DEVICE DESCRIPTION
The ZIIP+ Device is a hand-held, battery-powered device used with conductive gel to stimulate the face superficially through application of transcutaneous electrical currents. The device is powered by a Lithium-lon rechargeable battery, and it is shipped with a portable battery charger.
4
6. SUBSTANTIAL EQUIVALENCE
The ZIIP+ is substantially equivalent to the legally marketed ZIIP device (K161484) and the NuFACE Trinity Plus Device (K201782). The ZIIP+ Device has the identical output characteristics, principles of operation, and treatment method, and it has a similar indication for use as the predicate ZIIP Device. In addition, the ZIIP+ Device has the same intended use and indication for use [facial and neck toning] as the NuFACE Trinity Plus Device, as well as substantially equivalent technological characteristics and principles as operation, including Bluetooth Low Energy (BLE) capability.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| General Device Characteristics | |||
|---|---|---|---|
| ZIIP+ Subject Device | ZIIP Predicate | ||
| Device | NuFace Trinity Plus Predicate | ||
| Device | |||
| Manufacturer | ZIIP Inc. | ZIIP Inc. | NuFace |
| K Number | K212342 | K161484 | K201782 |
| Device Name | ZIIP+ | ZIIP | NuFace Trinity Plus |
| OTC/Rx | OTC | OTC | OTC |
| Med Dev Class | Class II | Class II | Class II |
| Product Code | NFO | NFO | NFO |
| Common Name | Transcutaneous Electrical | ||
| Nerve Stimulator | Transcutaneous | ||
| Electrical Nerve | |||
| Stimulator | Transcutaneous Electrical Nerve | ||
| Stimulator | |||
| Mechanism of Action | Microcurrent electrical | ||
| therapy to deliver skin | |||
| stimulation through cellular | |||
| response | Microcurrent | ||
| electrical therapy to | |||
| deliver skin | |||
| stimulation through | |||
| cellular response | Microcurrent electrical therapy to | ||
| deliver skin stimulation through | |||
| cellular response | |||
| Device Type | 21 CFR, Part 882.5890 | 21 CFR, Part | |
| 882.5890 | 21 CFR, Part 882.5890 | ||
| Indications for Use | |||
| /Intended Use | The ZIIP+ Device is | ||
| intended for facial and neck | |||
| stimulation and is indicated | |||
| for over-the-counter use. | The ZIIP Device is | ||
| intended for facial | |||
| stimulation and is | |||
| indicated for over- | |||
| the-counter use. | The NuFace Trinity Plus Device is | ||
| intended for facial and neck | |||
| stimulation and is indicated for over- | |||
| the-counter use. | |||
| Material/ Biocompatibility | Biocompatible materials | ||
| typically used in medical | |||
| devices and identical to | |||
| predicate ZIIP device | Biocompatible | ||
| materials typically | |||
| used in medical | |||
| devices. | Biocompatible materials typically | ||
| used in medical devices. | |||
| Power source | Internal Rechargeable | ||
| Lithium Ion Battery | Internal | ||
| Rechargeable Lithium | |||
| Ion Battery | Internal Rechargeable Lithium Ion | ||
| Battery | |||
| Performance standard | No known required | ||
| performance standards | No known required | ||
| performance | |||
| standards | No known required performance | ||
| standards | |||
| Sterility | Not applicable - this device | ||
| is not sold sterile | Not applicable - this | ||
| device is not sold | |||
| sterile | Not applicable - this device is not | ||
| sold sterile |
General Device Characteristics
5
| Human Factors | Ergonomic handheld design | Ergonomic handheld design | Ergonomic handheld design |
|---|---|---|---|
| Electrical Safety | Compliant with IEC 60601-1, 60601-1-2, 60601-1-11 | Compliant with IEC 60601-1, 60601-1-2 | IEC 60601-1, 60601-1-2, 60601-1-11 |
| Type of Energy | Electrical current | Electrical current | Electrical current |
| Charging Method | External wall adaptor | External wall adaptor | Wireless charging |
| Charging Circuitry | Internal to device | Internal to device | Internal to device |
| Special Requirements | Conductive gel | Conductive gel | Conductive gel primer |
| Wireless Capability | Bluetooth Low Energy (BLE) | N/A | Bluetooth Low Energy (BLE) |
Detailed Output Characteristics
| Detailed Output
| Specifications | ZIIP Subject Device | ZIIP Predicate Device | NuFace Trinity Plus |
|---|---|---|---|
| Power Source(s) | |||
| a) Method of Line | |||
| Current Isolation | One rechargeable Lithium-Ion Battery and External | ||
| Charger Isolation | One rechargeable Lithium-Ion Battery and External | ||
| Charger Isolation | One rechargeable Lithium-Ion Battery and External | ||
| Charger Isolation | |||
| b) Patient Leakage | |||
| Current | External Charger Included | External Charger Included | External Charger Included |
| 1. Normal | |||
| Condition | $46 \mu A$ | $46 \mu A$ | N/A - Battery Operated |
| 2. Fault Condition | $46 \mu A$ | $46 \mu A$ | N/A - Battery Operated |
| Number of Output | |||
| Modules | 1 | 1 | 1 |
| Number of Output | |||
| Channels | 1 | 1 | 1 |
| a) Synchronous or | |||
| Alternating | N/A - 1 Output Channel | N/A - 1 Output Channel | N/A - 1 Output Channel |
| b) Method of | |||
| Channel | |||
| Isolation | N/A - 1 Output Channel | N/A - 1 Output Channel | N/A - 1 Output Channel |
| Regulated Current or | |||
| Regulated Voltage | Both | Both | Both |
| Software/ | |||
| Firmware/ | |||
| Microprocessor | |||
| Controlled | Yes | Yes | Yes |
| Automatic Overload Trip | Not required because of | ||
| circuit design (Current and | |||
| Voltage Limited by Circuit | |||
| Design and Firmware) | Not required because of | ||
| circuit design (Current and | |||
| Voltage Limited by Circuit | |||
| Design and Firmware) | Not required because of | ||
| circuit design | |||
| Automatic No-Load Trip | Yes (Reversion to Fixed | ||
| Voltage Output) | Yes (Reversion to Fixed | ||
| Voltage Output) | Yes | ||
| Automatic Shut Off | Yes | Yes | Yes |
| Patient Override Control | Yes | Yes | Yes |
| Indicator Display | |||
| a) On/Off Status | Yes (LED Illumination on | ||
| Conduction) | Yes (LED Illumination on | ||
| Conduction) | Yes | ||
| b) Low Battery | Yes | Yes | Yes |
| c) Voltage/Current | |||
| Level | Yes (LED Illumination on | ||
| Target Current Levels) | Yes (LED Illumination on | ||
| Target Current Levels) | Yes |
6
| Output Specifications | ZIIP Subject Device | ZIIP Predicate Device | NuFace Trinity Plus |
|---|---|---|---|
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Pulsed Monophasic |
| Shape | Modulated Square Wave | Modulated Square Wave | Modulated Square Wave |
| Maximum Output Voltage | 154mV@500Ω | ||
| 465mV@52KΩ | |||
| 2.2V@10KΩ | 154mV@500Ω | ||
| 465mV@52KΩ | |||
| 2.2V@10KΩ | Not publicly available | ||
| Maximum Output Current | 309μA@500Ω | ||
| 232μΑ@2ΚΩ | |||
| 202μΑ@10ΚΩ | 309μA@500Ω | ||
| 232μΑ@2ΚΩ | |||
| 202μΑ@10ΚΩ | Not publicly available | ||
| Burst Mode (i.e. pulse | |||
| trains) | N/A - no burst mode | N/A - no burst mode | 20 (10 positive and 10 negative) |
| Pulses per second | 8.3 (@ 8.3 Hz) | ||
| Burst duration (seconds) | 2.4s (@ 8.3 Hz) | ||
| Duty Cycle [Line (b) x | |||
| Line (c)] (on time per | |||
| burst) | Duty Cycle: 50% | ||
| On time per burst: 20.2s | |||
| On time (seconds) | Constant | Constant | 60 ms (@8.3 Hz) |
| Off time (seconds) | None | None | 60 ms (@8.3 Hz) |
| Maximum Phase Charge | |||
| (μC) | 6.16 µC@500Ω | 6.16 µC@500Ω | 23.06 μC@500Ω |
| Maximum Current | |||
| Density (mA/cm2) | 0.34 mA/cm2 @500Ω | 0.34 mA/cm2 @500Ω | 0.78 mA/cm2 @500Ω |
| Maximum Power Density | |||
| (µW/cm2) | 3.44 W/cm2@500Ω | 3.44 W/cm2@500Ω | 3.22 µW/cm2@500Ω |
8. NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Comprehensive performance testing was performed to support the substantial equivalence determination for the ZIIP+ Device, including the following:
- . Electrical Safety Testing, including EMC. Specifically, the ZIIP+ Device was tested and found to be in compliance with:
- o IEC 60601- 1 -2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – requirements and tests) for radiated and power line conducted emissions
- IEC 60601-1 (Medical electrical equipment: Part 1: General requirements for basic o safety and essential performance) for Electrical Safety
- o IEC 60601-1-11 (Medical Electrical Equipment: Part 1-11: Requirements for medical electrical systems used in the home healthcare environment) for home healthcare devices
- Software Verification and Validation Testing
- The results of software verification and validation confirmed that the ZIIP+ Device meets and complies with the applicable software requirements specifications.
- Biocompatibility Evaluation
- The skin-contacting materials for ZIIP+ are identical to the skin-contacting materials for the predicate ZIIP device, which was evaluated and determined to be biocompatible; therefore, the ZIIP+ Device is biocompatible and substantially equivalent to the predicate device.
7
In summary, the safety and performance testing results for EMC, Electrical Safety, Wireless Coexistence, and Verification & Validation concluded that the ZIIP+ Device complies with the applicable standards and meets bench testing performance requirements.
9. CONCLUSION
The submitted documentation and performance testing demonstrates that the ZIIP+ device is substantially equivalent to the cited predicate devices in its intended use, principles of operation, design, and overall technological characteristics.