The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes . The TheraFace microcurrent is indicated for facial stimulation.

Device Description

The TheraFace microcurrent device consist of main control unit and its attachment applicators for microcurrent output which can be control by the device control button or APP in cell phone via Bluetooth connection. The device powered by one internal lithium rechargeable battery which can be charged by external battery charger. The device has the electrode contractors for facial stimulation by applying an electrical micro current to face skin. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 3 levels of output intensity, which can be adjusted by user. The low-level electrical current pulse goes through the face muscle and cause face muscle contraction for facial stimulation.

AI/ML Overview

The provided text is a 510(k) premarket notification for the TheraFace microcurrent device. This type of FDA submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent effectiveness through a rigorous clinical trial with defined acceptance criteria and human-in-the-loop studies.

Therefore, the document does not contain the specific information requested about acceptance criteria for device performance as a standalone, human-in-the-loop, or a multi-reader multi-case (MRMC) study, nor does it detail a study proving the device meets such criteria.

Instead, the submission demonstrates equivalence by:

Comparing the device's technical specifications and indications for use to a previously cleared predicate device (2 Face / Face Evolution - K171821). The core of the argument is that because the new device's parameters are similar to a device already deemed safe and effective for the stated purpose, it too is safe and effective.
Adhering to relevant electrical safety, EMC, and biocompatibility standards. This ensures the device itself is safe to operate and materials are biologically compatible.

Here's a breakdown of what can be extracted from the document, and what is missing based on your specific questions:

Information Present in the Document:

1. A table of acceptance criteria and the reported device performance:
* The document presents a comparison table (pages 4-6) showing the "Elements of Comparison" between the "Subject Device" (TheraFace microcurrent) and the "Primary Predicate Device" (2 Face / Face Evolution).
* This table serves as the "acceptance criteria" by proxy. The implicit acceptance criterion is that the new device's specifications should be "substantially equivalent" to the predicate, meaning similar enough not to raise new questions of safety or effectiveness. The "Reported Device Performance" for the TheraFace microcurrent is its listed specifications.
* Example from table:
* Element: Maximum Output Voltage (+/- 10%)
* Subject Device: 0.24V @ 500Ω; 1.0V @ 2kΩ; 5.0V @ 10kΩ
* Predicate Device: 0.31V @ 500Ω; 1.16V @ 2kΩ; 5.56V @ 10kΩ
* Remark: SE (Substantially Equivalent) - Note 3 explains why this difference is considered SE.
* The "Remarks" column often indicates "SE" (Substantially Equivalent), sometimes with cross-references to "Notes" (pages 8-9) that provide justification for minor differences. This is the primary method of "proving" the device meets the "acceptance criteria" of being substantially equivalent to the predicate.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* The document describes the device as a "hand-held device for over-the-counter aesthetic purposes" intended for "facial stimulation" (page 4).
* The performance is assessed by comparing its electrical output characteristics (waveform, voltage, current, frequency, pulse width) and safety features (automatic overload/no-load trip, shut-off) to the predicate device.
* This comparison to a predicate device is the "standalone" performance assessment in the context of a 510(k) for this type of device. There's no AI or algorithm that produces an output that would require a separate "standalone" performance evaluation in the way one might assess an AI diagnostic tool. The "software/firmware/microprocessor control" is noted, but its performance is implied to be acceptable if the device's electrical output specifications are met and it complies with relevant safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
* For the TheraFace microcurrent specifically, the evaluation relies on compliance with recognized consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 for electrical safety/EMC, and ISO 10993-5, ISO 10993-10 for biocompatibility). These standards inherently represent a form of "ground truth" for safety and performance for medical devices.
* There is no clinical "outcomes data," "pathology," or "expert consensus" in the sense of a diagnostic agreement presented in this 510(k) submission.

8. The sample size for the training set:
* Not applicable. This device is a transcutaneous electrical stimulator, not an AI/ML device that requires a "training set" for an algorithm. Its performance is based on its physical and electrical characteristics.

9. How the ground truth for the training set was established:
* Not applicable, as there is no training set for an AI/ML algorithm.

Information NOT present in the document (and why it's not applicable to this type of 510(k) submission):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No "test set" in the sense of a clinical data set is referenced. Performance is assessed through engineering testing against standards and comparison to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth is based on engineering standards and the predicate device's existing clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable due to the absence of a clinical "test set" requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting output.
Any numerical "performance" metrics for specific clinical outcomes (e.g., percent reduction in wrinkles, skin firmness improvement, etc.). The 510(k) process for this device type does not typically require clinical performance data beyond demonstrating electrical and physical equivalence to a predicate and compliance with safety standards.

In summary, this 510(k) primarily demonstrates the TheraFace microcurrent's safety and effectiveness by establishing its "substantial equivalence" to a previously cleared predicate device and compliance with relevant engineering and biocompatibility standards, rather than through a clinical study with traditional acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement.

Summary

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September 29, 2021

Theragun, Inc. % Thomas Padula Vice President Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, New Jersey 07006

Re: K212238

Trade/Device Name: TheraFace microcurrent Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: July 15, 2021 Received: July 19, 2021

Dear Thomas Padula:

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

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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 Injury 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

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Indications for Use

510(k) Number (if known) K212238

Device Name TheraFace microcurrent

Indications for Use (Describe)

The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes . The TheraFace microcurrent is indicated for facial stimulation.

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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510(K) PREMARKET NOTIFICATION FOR THERAFACE MICROCURRENT THERAGUN, INC.

510(k) Summary (as required by 807.92)

(1) SUBMITTER:

THERAGUN, Inc. 6100 Wilshire Blvd Suite 200 Los Angeles, CA 90048 Registration Number: 3012386142 FEI Number: 3012386142 Contact person: CJ Frederick - Director, Regulatory Compliance Telephone: 310-570-8341 Email: jaime@therabodycorp.com Date prepared: September 20, 2021

Application Correspondent:

Contact Person: Thomas Padula Company: Schiff & Company, Inc. Address: 583 Mountain Avenue, North Caldwell, NJ 07006 Tel: 201-317-8810 Email: thomaspadula(@schiffandcompany.com

(2) DEVICE NAME:

Trade Name: TheraFace microcurrent Common Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Device Classification: Class II Review Panel: Neurology; General & Plastic Surgery Regulation Number: 21 CFR 882.5890 Product Code: NFO

Sponsor	Heat In A Click
Device Name and Model	2 Face / Face Evolution
510(k) Number	K171821
Product Code	NFO
Regulation Number	882.5890
Regulation Class	II

(3) PREDICATE DEVICE(S): Substantial equivalence is based on following legally marketed devices.

(4) DESCRIPTION OF THEDEVICE:

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connection. The device powered by one internal lithium rechargeable battery which can be charged by external battery charger.

The device has the electrode contractors for facial stimulation by applying an electrical micro current to face skin. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 3 levels of output intensity, which can be adjusted by user. The low-level electrical current pulse goes through the face muscle and cause face muscle contraction for facial stimulation.

(5) INDICATIONS FOR USE:

The TheraFace microcurrent is a hand-held device for over-the-counter aesthetic purposes. The TheraFace microcurrent is indicated for facial stimulation.

(6) COMPARISON WITH PREDICATEDEVICES:

Following table is a comparison of TheraFace microcurrent and predicate devices.

TheraFace microcurrent is substantially equivalent in terms of the technological characteristics, features, specifications, materials, mode of operation and indications for use, to 2 Face Evolution - K 171821, cleared for marketing under510(K).

Elements ofComparison	Subject Device	Primary Predicate Device	Remark	Intended Use	The TheraFace microcurrent is ahand-held device for over-the-counteraesthetic purpose. The TheraFacemicrocurrent is indicated for facialstimulation.	2 Face / FaceEvolution is a hand-held device for over thecounter aesthetic purposes.(1) The EMS mode is indicated for facialstimulation.(2) The Photon mode: The red light isintended for the treatment of periorbitalwrinkles and the blue light is intendedfor the treatment of the mild to moderateinflammatory acne.	SENote 1(Only compared withits EMS function ofK171821)
Basic specification				Apply parts	Face	Face	SE
Device Name andModel	TheraFace microcurrent	2 Face / Face Evolution	--	Power Sources	Lithium battery :2x3.7V	DC 3.7V 2200mAh	SE
510 (K) Number	Applying	K171821	--	Method of LineCurrent Isolation	Battery Supply	Battery Supply	SE
Product Code	NFO	NFO	--	Number of Modes forMicro currentstimulation	l	1	SE
Regulation Number	882.5890	882.5890	--	Number of Channelsfor Micro currentstimulation	l	l	SE
Synchronous orAlternating	N/A	N/A	SE
Regulated Current orRegulated Voltage	Both	Both	SE
Software/Firmware/Microprocessorcontrol	Yes	Yes	ਟਜ
Automatic OverloadTrip	Yes	Yes	ਟਜ

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Automatic No-loadTrip		Yes.	Yes	SE
Automatic Shut Off		Yes.	Yes	SE
Patient OverrideControl		Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	SE
	LowBattery	Yes	Yes	SE
	Voltage/CurrentLevel	Yes	Yes	SE
Time Range		Micro current 5 minutes	EMS Mode (5 minutes)Photon Mode (5~7 minutes)	SE
Console weight		230g	200g	SENote 2
Waveform		Pulsed Biphasic	Pulsed Biphasic,	SE
Shape		Rectangular	Rectangular	SE
Maximum OutputVoltage (+/- 10%)		0.24V @ $500Ω$1.0V @ $2kΩ$5.0V @ $10kΩ$	0.31V @ $500Ω$1.16V @ $2kΩ$5.56V @ $10kΩ$	SENote 3

Maximum outputCurrent	500 μA @ 500 Ohm	620μΑ @ 500Ω	SE
	500 μA @ 2k Ohm	580μA @ 2kΩ
	500 μA @ 10k Ohm	556μΑ @ 10kΩ	Note 3
Frequency range	8.3 Hz	8.33 Hz	SE
Pulse width range	60ms	60ms	SE
Net Charge	0 μC @ 500Ω	0 μC @500 Ω	SE
Max Phase charge	29.4µC@ 500 Ohm	26.3μC@ 500 Ohm	SE Note 4
Maximum CurrentDensity	0.2mA/cm² @500Ω	0.33 mA/cm²@ 500Ω	SE Note 5
Maximum PowerDensity	23.1μW/cm² @500Ω	4.34 μW/cm² @ 500Ω	SE Note 5
ON time	60 ms	60 ms	SE
OFF time	60 ms	60 ms	SE
Contraction andRelaxation time	60 ms ON/OFF	60 ms ON/OFF	SE

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Material of device andconstruction	PC Plastic & Stainless Steel	ABS Plastic & Stainless Steel	SE Note 6
Bio-compatibility	All user directly contacting materialsare compliance with ISO10993-5,ISO10993-10	All user directly contacting materials arecompliance with ISO10993-5 andISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC 60601-1IEC 60601-1-11IEC 60601-2-10	Comply with: IEC 60601-1IEC 60601-1-11IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

Comparison in Detail(s):

Note 1:

There is multiple function operation mode in the predicate device, the subject device TheraFace microcurrent only has one micro-current operation mode. To this microcurrent mode, the subject device can be substantial equivalent to predicate device K171821.

Note 2:

Even there is console weight difference between subject device and predicate devices; but they all are portable medical device and comply with IEC60601-1 testing, such minor difference would not affect safety and effectiveness issue.

Note 3:(Maximum Output Voltage and Maximum Output Current):

The effect of micro current stimulation is determined by micro current output waveform and output current.

There is only minor difference about the output voltage and current between the subject device and the predicated devices, it can still obtain the same effect because our output voltage and output current are in the range which is between the value of K171821. Also, the subject device complies with IEC 60601-1, and IEC60601-2-10 which means we have proved its safety as well as the effectiveness comparing with the predicate devices. Therefore, the subject device and predicate devices are substantially

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equivalence on output voltage and current.

Note 4: (Max phase charge)

Even there is minor difference on the max phase charge between subject device and predicate device, but the pulse waveform is Pulsed Biphasic, and its net charge is 0 µC;

And the micro current waveform parameters comply with IEC60601-2-10, so the difference on max phase charge would not raise safety issue; and it would not affect effectiveness for facial stimulation. Therefore, such minor difference would not affect safety and effectiveness issue.

Note 5 (Maximum current density and Maximum power density):

The effect of micro current stimulation on facial skin are determined by micro-current output waveform and output current. The maximum current density and power density is the parameters related to safety of medical device.

For maximum current density, there is only little difference on it between the subject device and the predicated device K171821, it is little smaller than the value of K171821, so it would not raise safety issue. And viewing from max current density value in the predicate device K171821, the value of subject device is in the range of max current density between predicate device K171821. Therefore, such minor difference would not affect safety and effectiveness issue.

For maximum power density, the value of maximum power density of subject device is larger than the predicate device. But the maximum power density meets with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Also, the subject device complies with IEC 60601-1, and IEC60601-2-10 which means we have proved its safety as well as the effectiveness comparing with the predicate devices. Therefore, such minor difference would not affect safety and effectiveness issue.

Note 6

Even there is different for the material between subject device and predicate device, but its material complies with ISO10993-5, and ISO10993-10.

Finial Conclusion:

The TheraFace microcurrent device has the same indications use and technology characteristics as the predicate devices. TheraFace microcurrent device is as safe, as effective, and performs as well as the predicate devices.

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510(K) PREMARKET NOTIFICATION FOR THERAFACE MICROCURRENT THERAGUN, INC.

(7) PERFORMANCE STSTANDARDS APPLIED:

A series of studies were completed to demonstrate the substantial equivalence of TheraFace microcurrent to the predicate devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicates and included:

Biocompatibility

ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
ISO 10993-10 :2010, biological evaluation of medical devices part 10: tests for irritation and skin sensitization. (Biocompatibility).

Electrical Safety and Electromagnetic Compatibility

IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC / EN 60601-1-2: 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
IEC 60601-1-11 :2015. Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.
IEC 60601-2-10: 2012, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

TheraFace Micro-current Test Report, Theragun study TG-TheraFace-1010

AAMI TIR69:2017, ANSI C63.27-2017 Wireless Coexistence Test

Usability Engineering

Usability Study Report, Theragun study TG-Theraface microcurrent-013

(8) CONCLUSION:

TheraFace microcurrent has the same indications for use and technology characteristics as the predicate devices. TheraFace microcurrent is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 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).