(72 days)
Not Found
No
The summary describes a device that applies electrical microcurrents with adjustable intensity. There is no mention of AI, ML, image processing, or any data-driven learning or decision-making capabilities. The control is described as manual via a button or app.
No.
The device is intended for "aesthetic purposes" and "facial stimulation" for over-the-counter use, which are not considered therapeutic indications.
No
The device is indicated for "facial stimulation" and "over-the-counter aesthetic purposes," and its function is to cause "face muscle contraction for facial stimulation," not to diagnose any condition.
No
The device description explicitly states it consists of a "main control unit and its attachment applicators for microcurrent output," is "powered by one internal lithium rechargeable battery," and has "electrode contractors for facial stimulation." These are all physical hardware components, not solely software. While it mentions an "APP in cell phone via Bluetooth connection," this app controls the hardware device, making it a system that includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "over-the-counter aesthetic purposes" and "facial stimulation." This clearly describes a device used on the body for cosmetic or therapeutic effects, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description details a device that applies electrical microcurrent to the face skin to cause muscle contraction for facial stimulation. This is a physical interaction with the body, not an analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological samples (like blood, urine, tissue, etc.). There is no mention of reagents, assays, or diagnostic measurements.
In summary, the TheraFace microcurrent device is intended for external use on the face for aesthetic and stimulation purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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 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
2
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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3
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:
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
4
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 of
Comparison | Subject Device | Primary Predicate Device | Remark | Intended Use | The TheraFace microcurrent is a
hand-held device for over-the-counter
aesthetic purpose. The TheraFace
microcurrent is indicated for facial
stimulation. | 2 Face / Face
Evolution is a hand-held device for over the
counter aesthetic purposes.
(1) The EMS mode is indicated for facial
stimulation.
(2) The Photon mode: The red light is
intended for the treatment of periorbital
wrinkles and the blue light is intended
for the treatment of the mild to moderate
inflammatory acne. | SE
Note 1
(Only compared with
its EMS function of
K171821) |
|-------------------------------------------------|-------------------------------|--------------------------|--------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Basic specification | | | | Apply parts | Face | Face | SE |
| Device Name and
Model | TheraFace microcurrent | 2 Face / Face Evolution | -- | Power Sources | Lithium battery :2x3.7V | DC 3.7V 2200mAh | SE |
| 510 (K) Number | Applying | K171821 | -- | Method of Line
Current Isolation | Battery Supply | Battery Supply | SE |
| Product Code | NFO | NFO | -- | Number of Modes for
Micro current
stimulation | l | 1 | SE |
| Regulation Number | 882.5890 | 882.5890 | -- | Number of Channels
for Micro current
stimulation | l | l | SE |
| Synchronous or
Alternating | N/A | N/A | SE | | | | |
| Regulated Current or
Regulated Voltage | Both | Both | SE | | | | |
| Software/Firmware/
Microprocessor
control | Yes | Yes | ਟਜ | | | | |
| Automatic Overload
Trip | Yes | Yes | ਟਜ | | | | |
5
6
| Automatic No-load
| Trip | Yes. | Yes | SE | |
|---|---|---|---|---|
| Automatic Shut Off | Yes. | Yes | SE | |
| Patient Override | ||||
| Control | Yes | Yes | SE | |
| Indicator | ||||
| Display | On/Off | |||
| Status | Yes | Yes | SE | |
| Low | ||||
| Battery | Yes | Yes | SE | |
| Voltage/ | ||||
| Current | ||||
| Level | Yes | Yes | SE | |
| Time Range | Micro current 5 minutes | EMS Mode (5 minutes) | ||
| Photon Mode (5~7 minutes) | SE | |||
| Console weight | 230g | 200g | SE | |
| Note 2 | ||||
| Waveform | Pulsed Biphasic | Pulsed Biphasic, | SE | |
| Shape | Rectangular | Rectangular | SE | |
| Maximum Output | ||||
| Voltage (+/- 10%) | 0.24V @ $500Ω$ | |||
| 1.0V @ $2kΩ$ | ||||
| 5.0V @ $10kΩ$ | 0.31V @ $500Ω$ | |||
| 1.16V @ $2kΩ$ | ||||
| 5.56V @ $10kΩ$ | SE | |||
| Note 3 | ||||
| Maximum output | ||||
| Current | 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 Current | ||||
| Density | 0.2mA/cm² @500Ω | 0.33 mA/cm²@ 500Ω | SE Note 5 | |
| Maximum Power | ||||
| Density | 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 and | ||||
| Relaxation time | 60 ms ON/OFF | 60 ms ON/OFF | SE |
7
8
| Material of device and
| construction | PC Plastic & Stainless Steel | ABS Plastic & Stainless Steel | SE Note 6 |
|---|---|---|---|
| Bio-compatibility | All user directly contacting materials | ||
| are compliance with ISO10993-5, | |||
| ISO10993-10 | All user directly contacting materials are | ||
| compliance with ISO10993-5 and | |||
| ISO10993-10 requirements. | SE | ||
| Electrical Safety | Comply with IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| IEC 60601-2-10 | Comply with: IEC 60601-1 | ||
| IEC 60601-1-11 | |||
| IEC 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
9
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.
10
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.