The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

Device Description

The Talent-Pro Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes, prevention or retardation of disuse atrophy. Talent-Pro Electromagnetic Stimulator consists of the Main body, Transducer for magnetic stimulation

AI/ML Overview

The provided text describes the Talent-Pro Electromagnetic Stimulator, a device for neuromuscular tissue stimulation, and assesses its substantial equivalence to a predicate device (HPM-6000, K160992) for FDA 510(k) clearance. However, the document does not contain acceptance criteria or study results for a device that relies on artificial intelligence (AI) or machine learning.

The document outlines performance and safety data relevant to an electromagnetic stimulator, which is a physical device, not an AI/ML algorithm. Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or studies proving device performance based on the input document.

The "Safety & Performance Data" section primarily addresses:

Biocompatibility Testing: Ensuring the materials are safe for human contact.
Design Verification and Validation Testing: Verifying the device meets predefined safety and performance requirements (e.g., magnetic field output, intensity control, pulse width/frequency, stability, safety devices, simultaneous operation prevention).
Electrical Safety and Performance Testing: Compliance with IEC standards.
Shipping Validation: Ensuring the device withstands transport.

These tests are standard for medical hardware devices and do not involve AI/ML performance metrics such as AUC, sensitivity, specificity, or human-in-the-loop studies for AI assistance.

Summary

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Remed Co., Ltd % Kyungyoon Kang CEO K-Biotech 201 South 4th Street. Suite 727 San Jose. California 95112

Re: K202031

Trade/Device Name: Talent-Pro Electromagnetic Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: January 25, 2021 Received: February 8, 2021

Dear Kyungyoon Kang:

We have reviewed vour 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 af fecting 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 equi valence 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 to pic. 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,

Patrick Antkowiak. PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202031

Device Name

Talent-ProTM Electromagnetic Stimulator

Indications for Use (Describe)

The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, REMED Co., Ltd. submits the following information as premarket notification for the proposed device, Talent-Pro Electromagnetic Stimulator.

l. SUBMITTER
Company: REMED Co., Ltd. ●
Address: #301-#303 Migun Techno World II, 187, Techno 2-Ro, Yuseong-gu, Daejeon, Republic of Korea, Postal code: 34025
Tel: 82-42-934-5560
Fax: 82-42-934-5562 ●
510(k) Number: TBD .

510(k) Lead: Seong Hyeon Kim, K-Bio Solutions Manager (sarah.kim @kbiotechsolutions.com, Tel: 82-2-597-2700)

Date Prepared: June 22nd, 2020

II. PROPOSED DEVICE

Type of Submission: Traditional Premarket Notification ●
Trade Name of Device: Talent-Pro Electromagnetic Stimulator ●
Classification Name of Device: Stimulator, Muscle, Powered
Review Panel: Physical Medicine ●
. Regulation Number: 21 CFR 890.5850
Requlatory Class: Class II
Product Code: IPF ●

= PREDICATE DEVICE

HPM-6000 (K160992, Manufacturer: BTL Industries, Inc.) The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION IV.

The proposed, Talent-Pro Electromagnetic Stimulator is substantially equivalent to the predicate device. HPM-6000 (K160992. Manufacturer: BTL Industries. Inc.),

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The intended use and indications for use of the proposed device are identical to the predicate device. The fundamental scientific, and technological characteristics of the proposed Talent-Pro Electromagnetic Stimulator and principles of Talent-Pro Electromagnetic Stimulator operation are similar to the predicate, except differences primarily shown in the product dimensions, which are assessed not to raise different questions in terms of safety and effectiveness compared to the predicate device.

V. INDICATIONS FOR USE
The Talent-Pro™ Electromagnetic Stimulator is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Talent-Pro™ Electromagnetic Stimulator is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

Relaxation of muscle spasms -
-Prevention or retardation of disuse atrophy
Increasing local blood circulation ।
-Muscle re-education
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion -
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed Talent-Pro Electromagnetic Stimulator and predicate device, HPM-6000 (K160992) share the same intended use and indications for use.

The fundamental technological characteristics and critical functional features of the Talent-Pro Electromagnetic Stimulator are similar to the predicate device, HPM-6000 (K160992). The minor differences in the external appearance and dimensions of the products do not raise different questions in safety and effectiveness compared to the predicate device. The favorable results of the design verification and electrical safety testing of the Talent-Pro Electromagnetic Stimulator have demonstrated that the proposed device has met the predetermined design requirements and the FDA's recognized standards, including the electrical safety and performance standards and EMC standards as the same as the predicate device.

The design and function of the Talent-Pro Electromagnetic Stimulator do not involve a new or different technological principle that would be considered to raise different questions in safety and effectiveness compared to the predicate device. The principle of operation, critical function and clinical use and application are the same as the predicate device, HPM-6000 (K160992).

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Detailed comparisons of intended use/indications for use, technological characteristics and critical functional features between the proposed and predicate devices are provided in Table 1 below.

ComparisonItem	Proposed Device	Predicate Device	Assessment ofSubstantial Equivalence
Trade/DeviceName	Talent-ProElectromagneticStimulator	HPM-6000	N/A
Product Codeand Regulation	21 CFR 890.5850IPF-Stimulator,Muscle, Powered	21 CFR 890.5850IPF-Stimulator,Muscle, Powered	Same
510k Number	N/A	K160992	N/A
Manufacturer	REMED Co., Ltd.	BTL Industries, Inc.	N/A
Application	Muscle Stimulation	Muscle Stimulation	Same
IntendedUse/Indicationsfor Use	The Talent-Pro™ElectromagneticStimulator isintended to be usedunder medicalsupervision foradjunctive therapyfor the treatment ofmedical diseasesand conditions.The Talent-Pro™ElectromagneticStimulator is indicatedfor use in stimulatingneuromuscular tissuefor bulk muscleexcitation in the legsor arms forrehabilitativepurposes.	The HPM-6000 deviceis intended to be usedunder medicalsupervision foradjunctive therapy forthe treatment ofmedical diseases andconditions.The HPM-6000 deviceis indicatedfor use in stimulatingneuromuscular tissuefor bulk muscleexcitation in the legs orarms for rehabilitativepurposes.Indications for Use forMuscle Stimulators:-Relaxation of MuscleSpasms-Prevention orRetardation of DisuseAtrophy-Increasing LocalBlood Circulation-Muscle Re-education-Immediate Post-	Same
	blood circulation- Muscle re-education- Immediate post-surgical stimulation ofcalf muscles toprevent venousthrombosis- Maintaining orincreasing range ofmotion	Surgical Stimulation ofCalf Muscles toPrevent VenousThrombosis-Maintaining orIncreasing Range ofMotion
ElectricalProtection	Class II, BF	Class II, BF	Same
Interface	Touch screen	Touch-Screen	Same
Type of Energy	Magnetic Field	Magnetic Field	Same
Type ofApplicator	Single Magnetic Coil	Single Magnetic Coil	Same
Number ofMagnetic Coilsin the Applicator	1	1	Same
Number ofApplicators	2	2	Same
Color TouchScreen	8 inch20.32 cm800 x 480 pixel	8.4 inch21.3 cm800 x 400 pixel	SimilarA minute difference in thetouch screen size, andenhanced resolutionquality with a higher levelof pixel do not raise newquestions of safety andeffectiveness.
Type ofOperation	Continuous	Continuous	Same
PulseRepetitionRange	1-150 Hz	1-150 Hz	Same
Magnetic FieldIntensity	Applicator A: 1.00-2.5TApplicator B: 1.00-2.5T	299-1 applicator:0.5-1.8T299-2 applicator:0.7-2.5T	Similar
Pulse Duration(±20%)	280μs	280μs	Same
PulseAmplitude	0-100%	0-100%	Same
Therapy Time	Up to 60 min	Up to 60 min	Same
OperatingTemperature	10-30°C	10-30°C	Same
OperatingHumidity	30-85%	30-75%	Similar
Shape ofStimulationPulse	Sine, Biphasic	Sine, Biphasic	Same
Energy Source	120V~, 60Hz, 1500A	100-240 V AC, 50-60Hz, Max 14A	Talent-Pro's energy sourceis set up to be applicable tothe US customer's use.
ExternalExchangeableFuse	Yes	Yes	Same
SystemDimensions(Width x Heightx D/Length)	541.6 x500.7x1072.9 mm(21.3 x 19.7 x 1072.9in)	500 x 580 x 230 mm(20 x 23 x 9 in)	Similar, a minor differencein the overall externaldimensions is not expectedto raise different questionsof the device profile insafety and effectivenesscompared to the predicate.
System Weight	60 kg (132.3 lb)	33 kg (73lb)	Similar
Position	Vertical-On Castors	Vertical-On Castors	Same

Table 1: Substantial Equivalence Assessment

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SAFETY & PERFORMANCE DATA VII.

The following safety and performance data were provided in support of this substantial equivalence determination.

A Biocompatibility Testing

In order to meet the FDA's consensus standards for biocompatibility requirements identified in the FDA Guidance titled, "Use of ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process (Issued June 16, 2016)", GLP biocompatibility testing of the proposed, Talent-Pro Electromagnetic Stimulation System has been completed with the favorable results of the biocompatibility testing.

Our biocompatibility risk assessments of the Talent-Pro Electromagnetic Stimulation System have concluded that it is warranted no additional biocompatibility testing of the proposed device is necessary.

Biocompatibility Testing Evaluations of Talent-Pro Electromagnetic Stimulation System Per ISO 10993 and FDA Guidance (June 16, 2016):

Cytotoxicity
Repeated Patch Dermal Sensitization Test (GLP Buehler Method ● Modified for Medical Devices)
ISO Primary Skin Irritation Test

A Design Verification and Validation Testing

Design Verification and Validation (DV&V) testing was performed to verify that the proposed Talent-Pro Electromagnetic Stimulator meets the pre-defined safety and performance requirements. Testing was also conducted to verify the effectiveness of the implemented risk control measures to mitigate the risks identified within the risk management process (per ISO 14971:2012, Medical Devices - Application of Risk Management to Medical Devices). The following design verification, or performance testing of Talent-Pro Electromagnetic Stimulator have been completed with the favorable test results, meeting the applicable ISO standards and FDA's recognized consensus standards related to evaluation of performance of Talent-Pro Electromagnetic Stimulator.

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The favorable results of the design verification and validation tests have demonstrated that the design output of the proposed Talent-Pro Electromagnetic Stimulator matches its design input and is appropriate to be used for the intended use, which support its substantially equivalent profile to the predicate device.

The following design verification, validation, electrical safety and performance testing of the Talent-Pro Electromagnetic Stimulator have been comprehensively completed with the favorable test results:

Design Verification Performed (Safety and Performance Testing)

CH1 Magnetic Field Output Magnetic Field Strength Test ●
CH2 Magnetic Field Output Magnetic Field Strength Test ●
CH1 Magnetic Field Intensity Control Performance Test ●
CH2 Magnetic Field Intensity Control Performance Test ●
CH1 Magnetic Field Stimulation Pulse Width Test ●
CH2 Magnetic Field Stimulation Pulse Width Test ●
CH1 Magnetic Field Stimulation Pulse Frequency Test ●
CH2 Magnetic Field Stimulation Pulse Frequency Test
Stability Test of Magnetic Field Output ●
Magnetic Field Safety Device Test ●
Simultaneous Operation Prevention Test
Medical Device Inspection Test ●

IEC Electrical Safety and Performance Testing

IEC 60601-1 .
IEC 60601-1-6 ●
IEC 62366 ●
IEC 60601-2-10 ●
IEC 60601-1-2 ●

> Shipping Validation

. Shipping Validation Test
The results of the shipping validation test demonstrate that the proposed, Talent-Pro Electromagnetic Stimulator has met all the pre-determined shipping validation test requirements.

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VIII. CONCLUSIONS

In conclusion, the proposed Talent-Pro Electromagnetic Stimulator is assessed to be substantially equivalent to the predicate device. HPM-6000 (K160992). The proposed Talent-Pro Electromagnetic Stimulator shares the same intended use, indications for use and operation principle as the predicate device. HPM-6000 (K160992). The technological characteristics of the Talent-Pro Electromagnetic Stimulator are similar to the predicate and the minor differences are assessed not to raise different questions in terms of safety and effectiveness.

The comprehensive evaluations of the Talent-Pro Electromagnetic Stimulator along with the aforementioned design verification and validation testing assessments provide assurance that the Talent-Pro Electromagnetic Stimulator has met the predetermined design requirements per the FDA's recognized consensus standards which have been applied to the predicate device in the same manner.

The comprehensive assessments all point to the conclusion that the Talent-Pro Electromagnetic Stimulator is substantially equivalent to the predicate, HPM-6000 (K160992).

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).