(288 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on electromagnetic stimulation without suggesting advanced algorithmic processing.
Yes
The device is intended for "adjunctive therapy for the treatment of medical diseases and conditions" and its indications for use include "rehabilitation purposes," "relaxation of muscle spasms," and "prevention or retardation of disuse atrophy," all of which are therapeutic applications.
No
Explanation: The device description and intended use clearly state that the device is a stimulator for therapeutic/rehabilitative purposes (e.g., muscle excitation, relaxation of spasms, increasing blood circulation, preventing atrophy), not for diagnosis. There is no mention of diagnostic functions such as detection, measurement, or analysis for the purpose of identifying a disease or condition.
No
The device description explicitly states that the Talent-Pro Electromagnetic Stimulator "consists of the Main body, Transducer for magnetic stimulation," indicating the presence of hardware components beyond just software.
Based on the provided information, the Talent-Pro™ Electromagnetic Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "adjunctive therapy for the treatment of medical diseases and conditions" and "stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes." This describes a therapeutic device that interacts directly with the patient's body.
- Device Description: The description confirms it's an "Electromagnetic Stimulator" that uses a "Transducer for magnetic stimulation." This further supports its function as a device that applies energy to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
Therefore, the Talent-Pro™ Electromagnetic Stimulator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
IPF
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs or arms, calf muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under medical supervision
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)
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.
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.
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.
HPM-6000 (K160992
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the date May 6, 2021. The text is in a simple, sans-serif font. The date is written in the standard month-day-year format. The text is black on a white background.
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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
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 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
2
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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3
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 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
The proposed, Talent-Pro Electromagnetic Stimulator is substantially equivalent to the predicate device. HPM-6000 (K160992. Manufacturer: BTL Industries. Inc.),
4
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).
5
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.
| Comparison
Item | Proposed Device | Predicate Device | Assessment of
Substantial Equivalence |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device
Name | Talent-Pro
Electromagnetic
Stimulator | HPM-6000 | N/A |
| Product Code
and Regulation | 21 CFR 890.5850
IPF-Stimulator,
Muscle, Powered | 21 CFR 890.5850
IPF-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 |
| Intended
Use/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. | The HPM-6000 device
is intended to be used
under medical
supervision for
adjunctive therapy for
the treatment of
medical diseases and
conditions.
The HPM-6000 device
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- | Same |
| | blood circulation
- Muscle re-education
- Immediate post-
surgical stimulation of
calf muscles to
prevent venous
thrombosis - Maintaining or
increasing range of
motion | Surgical Stimulation of
Calf Muscles to
Prevent Venous
Thrombosis
-Maintaining or
Increasing Range of
Motion | |
| Electrical
Protection | Class II, BF | Class II, BF | Same |
| Interface | Touch screen | Touch-Screen | Same |
| Type of Energy | Magnetic Field | Magnetic Field | Same |
| Type of
Applicator | Single Magnetic Coil | Single Magnetic Coil | Same |
| Number of
Magnetic Coils
in the Applicator | 1 | 1 | Same |
| Number of
Applicators | 2 | 2 | Same |
| Color Touch
Screen | 8 inch
20.32 cm
800 x 480 pixel | 8.4 inch
21.3 cm
800 x 400 pixel | Similar
A minute difference in the
touch screen size, and
enhanced resolution
quality with a higher level
of pixel do not raise new
questions of safety and
effectiveness. |
| Type of
Operation | Continuous | Continuous | Same |
| Pulse
Repetition
Range | 1-150 Hz | 1-150 Hz | Same |
| Magnetic Field
Intensity | Applicator A: 1.00-
2.5T
Applicator B: 1.00-
2.5T | 299-1 applicator:0.5-
1.8T
299-2 applicator:0.7-
2.5T | Similar |
| Pulse Duration
(±20%) | 280μs | 280μs | Same |
| Pulse
Amplitude | 0-100% | 0-100% | Same |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Operating
Temperature | 10-30°C | 10-30°C | Same |
| Operating
Humidity | 30-85% | 30-75% | Similar |
| Shape of
Stimulation
Pulse | Sine, Biphasic | Sine, Biphasic | Same |
| Energy Source | 120V~, 60Hz, 1500A | 100-240 V AC, 50-60
Hz, Max 14A | Talent-Pro's energy source
is set up to be applicable to
the US customer's use. |
| External
Exchangeable
Fuse | Yes | Yes | Same |
| System
Dimensions
(Width x Height
x D/Length) | 541.6 x500.7
x1072.9 mm
(21.3 x 19.7 x 1072.9
in) | 500 x 580 x 230 mm
(20 x 23 x 9 in) | Similar, a minor difference
in the overall external
dimensions is not expected
to raise different questions
of the device profile in
safety and effectiveness
compared 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
6
7
8
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.
9
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.
10
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).