ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS/NMES:

ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

TENS:

ManaFlexx2 (MF002-RX) is intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis

PMS/NMES:

ManaFlexx2 (MF002-RX) is intended for the following use:

Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Device Description

The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there are two snap connectors on the rear of the device which are for connecting with electrode. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, and there is a LED screen to display the selected mode, intensity level and charging status.

The electrode is a long strip shape with a size of 21cm x 5.3cm, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit.

The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.

AI/ML Overview

The provided text is a 510(k) Summary for the ManaFlexx 2 device, a TENS/PMS/NMES unit. It details the device's comparison to predicate devices and summarizes non-clinical performance testing. However, it explicitly states: "Clinical testing was not performed on the device."

This means there is no study described that proves the device meets acceptance criteria based on human-in-the-loop performance, expert consensus, or clinical outcomes. The acceptance criteria and "study that proves the device meets the acceptance criteria" in this document refer exclusively to non-clinical performance testing against recognized standards.

Below is a breakdown of the requested information based only on the provided text, focusing on the non-clinical performance testing mentioned. Many points cannot be answered as they relate to clinical studies that were "not performed."

Device: ManaFlexx 2 (model: MF002-RX, MF002-OTC)

1. A table of acceptance criteria and the reported device performance

Test Title	Acceptance Criteria	Reported Device Performance
General requirements for basic safety and essential performance (against ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021])	The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard.	Pass
Electromagnetic disturbances (against IEC 60601-1-2 Edition 4.1 2020-09)	No degradation of performance was found during test.	Pass
Requirements for medical electrical equipment and systems used in the home healthcare environment (against IEC 60601-1-11 Edition 2.1 2020-07)	The device operates normally, and can provide basic safety and essential performance.	Pass
Requirements for the basic safety and essential performance of nerve and muscle stimulators (against IEC 60101-2-10 Edition 2.1 2016-04)	The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard.	Pass
Dispersion and Shelf Life Test	The impedance change before the new and aging electrode, used electrode should not exceed ± 20% of the initial average impedance.	Pass
Waveform & Output Test	According to "IEC 60601-2-10, Particular requirements for the safety of nerve and muscle stimulators", the limitation of output parameters with 500Ω resistance load should meet the following requirement:● The output current limit r.m.s. with 500Ω resistance load is 80mA● For pulse durations of less than 0.1s, the pulse energy with 500Ω resistance load shall not exceed 300mJ per pulse.● The output voltage shall not exceed a peak value of 500V, when measured under open-circuit condition.Otherwise, the following two Acceptance Criteria for the device according to FDA Guidance:● Maximum Power Density ≤ 0.25 (W/cm²)	Pass
Biocompatibility testing (against predicate SM Electrodes cleared in K183154)	The conductive hydrogel electrode of ManaFlexx 2 is identical to the SM Electrodes as it was cleared in K183154, 2019, in formulation, processing, and sterilization, and no other chemicals have been added.	Deemed identical
Usability Testing (against IEC 62366-1 and IEC 60601-1-6)	The device complies with IEC 62366-1 and IEC 60601-1-6.	Complies
Software verification and validation testing (against FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")	Software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. (Implied acceptance is that the V&V was successful for this concern level).	Conducted and documented
Cybersecurity	No external interfaces, thus no need for cybersecurity evaluation per FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."	Not applicable
Shelf-life testing	Maintain performance in 2 years (acceptable criteria similar to K171722).	Maintain performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: For performance testing (bench tests), the sample size is stated as "The test sample is the final, finished product." No specific number is given, but typically this means a small number of units (e.g., 3-5) are tested to demonstrate compliance.
Data Provenance: The tests are non-clinical, lab-based performance tests against international standards. The 510(k) application is from ManaMed, Inc. (USA) with an application correspondent in Guangzhou, Guangdong, China. The testing likely occurred in a lab affiliated with the manufacturer or a third-party testing facility, potentially in China (where the correspondent is located). The data is generated prospectively as part of the regulatory submission process.

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 as typically understood in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) was not established because "Clinical testing was not performed on the device." The "ground truth" for these tests is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC, ANSI AAMI).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human consensus or expert review processes, which were not part of the described non-clinical testing.

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

No. "Clinical testing was not performed on the device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical TENS/PMS/NMES unit, not an AI algorithm. The performance tests are for the electrical and mechanical functions of the device itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is the adherence to the published performance specifications and limits defined by the referenced international consensus standards (e.g., IEC 60601 series, ANSI AAMI ES60601-1). This is a technical standard compliance model, not a clinical "ground truth."

8. The sample size for the training set

Not applicable. The device is a physical stimulator, not an AI/ML model that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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November 3, 2023

ManaMed, Inc % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510000 China

Re: K231569

Trade/Device Name: ManaFlexx 2 (model: MF002-RX. MF002-OTC) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, GZJ, IPF Dated: May 25, 2023 Received: May 31, 2023

Dear Cassie Lee:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Robert Kang -S

for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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) K231569

Device Name ManaFlexx 2(Model: MF002-RX, MF002-OTC)

Indications for Use (Describe) For Over-The-Counter Use:

TENS:

PMS/NMES:

For Prescription Use:

TENS:

ManaFlexx2 (MF002-RX) is intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis

PMS/NMES:

ManaFlexx2 (MF002-RX) is intended for the following use:

Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.

1. Submitter's Information

Name: ManaMed Inc Address: 5240 W. Charleston Blvd. Suite 150.Las Vegas, NV 89146.USA Postal code: 89146 Contact name: Trevor Theriot Title: President Tel: 949-632-0355 Fax: 940-287-3510 E-mail: ttheriot@manamed.net

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

2. Date of the summary prepared: November 1, 2023

3. Subject Device Information

Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle Stimulation (PMS) unit, blood circulation, and muscle performance Trade Name: ManaFlexx 2 Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter Model: MF002-RX, MF002-OTC Regulatory Class: II Product Code: NUH, NGX, NYN, GZJ, IPF Regulation Number: 21 CFR 882.5890

Predicate Device Information Predicate Device1 (Primary):

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510(K) Number: K191151 Company Name: JKH USA, LLC Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Trade Name: JKH Stimulator Plus Model: PL-029K5BL, PL-029K15, PL-029T Regulation Number: 21 CFR 882.5890\ Regulatory Class: II Product Code: NUH, NGX, NYN, GZJ, IPF, IRT

Reference Device:

510(K) Number: K200237 Company Name: Shenzhen Kentro Medical Electronics Co., Ltd Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, China Trade Name: Transcutaneous Electronic Nerve Stimulator Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2302, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494. Regulation Number: 21 CFR 890.5850 Regulatory Class: II Product Code: NUH

5. Device Description

The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.

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6. Intended Use / Indications for Use

For Over-The-Counter Use: TENS:

ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS/NMES:

ManaFlexx 2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

ManaFlexx 2 (MF002-OTC)is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

TENS:

ManaFlexx 2 (MF002-RX) is intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis

PMS/NMES:

ManaFlexx 2 (MF002-RX) is intended for the following use:

Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

7. Comparison to predicate device and conclusion

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

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Elements of Comparison	Subject Device	Primary Predicate Device	Reference Device	Remark
Device Name and Model	ManaFlexx 2 (MF002-RX, MF002-OTC)	JKH Stimulator Plus (PL-029K5BL, PL-029K15, PL-029T)	TranscutaneousElectronic NerveStimulator (Model:KTR-2401, KTR-2402,KTR-2411, KTR-2412,KTR-2301, KTR-2302,KTR-2341, KTR-2342,KTR-2491, KTR-2492,KTR-2493, KTR-2494)	--
510(k) Number	K231569	K191151	K200237	--
Product Code	NUH, NGX, NYN, GZJ, IPF	NUH, NGX, NYN, GZJ, IPF, IRT	NUH	SimilarNote 1
Intended Use	For Over-The-Counter Use:TENS:ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.PMS/NMES:ManaFlexx 2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.ManaFlexx 2 (MF002-OTC)is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.	Over-The-Counter Use:TENS:PL-029K5BL, PL-029K15, and PL-029T are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.PL-029K5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.The device of PL-029K5BL and PL-029K15 may be used during sleep.The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes.PMS:PL-029K5BL, PL-029K15, and PL-029T are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for	TranscutaneousElectronic NerveStimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.	SimilarNote 1

	For Prescription Use:TENS:ManaFlexx 2 (MF002-RX) isintended for the followinguse:- Symptomatic relief andmanagement of chronic,intractable pain- Adjunctive treatment forpost-surgical and post-trauma acute pain- Relief of pain associatedwith arthritisPMS/NMES:ManaFlexx 2 (MF002-RX) isintended for the followinguse:- Temporary relaxation ofmuscle spasm- Prevention or retardationof disuse atrophy- Muscle re-education- Maintaining or increasingrange of motion- Increase of local blood flowin the treatment area- Prevention of post-surgicalvenous thrombosis throughimmediate stimulation of calfmuscles	use in any therapy or for thetreatment of any medicalconditions or diseases.PL-029K5BL, PL-029K15,and PL-029T are alsointended to temporarilyincrease local bloodcirculation in the healthymuscles of lowerextremities.Heating: The device of PL-029T is intended fortemporary relief of minoraches and pains.Prescription Use:TENS: PL-029K5BL, PL-029K15, and PL-029T areintended for the followinguse: - Symptomatic reliefand management ofchronic, intractable pain -Adjunctive treatment forpost-surgical and post-trauma acute pain - Reliefof pain associated witharthritisPMS: PL-029K5BL, PL-029K15, and PL-029T areintended for the followinguse: - Temporary relaxationof muscle spasm -Prevention or retardation ofdisuse atrophy- Muscle re-education- Maintaining or increasingrange of motion- Increase of local bloodflow in the treatment area- Prevention of post-surgicalvenous thrombosis throughimmediate stimulation ofcalf muscles
Prescription or OTC	OTC and Prescription	OTC and Prescription	OTC	Same
Power Source(s)	Rechargeable battery	Rechargeable or non-rechargeable battery	For KTR-23XXseries: CR2032;3Vdc; 240mAhFor KTR-24XXseries: PL301526;3.7Vdc, 250mAh	Same
Method of line currentisolation	Battery supply	Battery supply	Not public available	Same
Patient leakage current:	<10 µA	N/A	NC: DC: 0.5µA	Different
Normal condition (μΑ)				SFC: DC: 0.6μΑ	Note 2
Patient leakage current: Single Fault condition (μΑ)		<50 μΑ	N/A	Not public available	DifferentNote 2
Average DC current through electrodes when device is on but no pulses are being applied (mA)		0	0	< 0.01μΑ	Same
Number of Output Modes		2	PL-029K5BL: 6-8PL-029K15: 1-4PL-029T: 8	For KTR-23XXseries: 3 modesFor KTR-240X series& KTR-241X series: 3modesFor KTR 249X series:15 modes	DifferentNote 3
Number of Output		1	1-2	1	Same
Synchronous/Alternating?		N/A	N/A	Synchronous	Same
Method of Channel Isolation		N/A	N/A	Not public available	Same
Regulated Current or Regulated Voltage?		Voltage	Voltage	Voltage Control	Same
Software/Firmware/Microprocessor Control?		Yes	Yes	Yes	Same
Automatic Overload Trip?		No	No	No	Same
Automatic No-Load Trip?		Yes	Yes	No	Same
Automatic Shut Off?		Yes	Yes	Yes	Same
User Override Control?		Yes	Yes	Yes	Same
Indicator display	On/Offstatus?	Yes	Yes	Yes	Same
	Lowbattery?	No	Yes	No	Same
	Voltage/current level?	Yes	Yes	Yes	Same
Time range (minutes)		30	PL-029K5BL: 10-540 PL-029K15: 10-60 PL-029T:10-60	15 min	SimilarNote 4
Compliance with Voluntary Standards?		Yes	Yes	Not public available	Same
Compliance with 21CFR 898?		Yes	Yes	Not public available	Same
Weight (g)		17.8g	PL-029K5BL: 40PL-029K15: 35	Main Unit:31gElectrode:	SimilarNote 5
		PL-029T: 70
			EPAD-H01: 13g,EPAD-H02: 13g,EPAD-F01: 15g,EPAD-F02: 10g,EPAD-F03: 12g,EPAD-B01: 8g,EPAD-T01: 8g,EPAD-Z01: 55g
Dimensions (mm) (L x W x D)	59.84014.4mm	PL-029K5BL: 66x56x18PL-029K15: 70x62x16PL-029T: 95x55x15	Model KTR-2401:$\Phi$ 46.3x12.07;Model KTR-2402:$\Phi$ 46.28x11.69Model KTR-2411:46.29x46.29x12.08;Model KTR-2412:46.29x46.29x11.59;Model KTR-2301:$\Phi$ 49.8x12.44;Model KTR-2302:$\Phi$ 49.8x12.48Model KTR-2341:48.8x48.8x12.42;Model KTR-2342:48.8x48.8x12.45;Model KTR-2491:$\Phi$ 49.8x12.44;Model KTR-2492:$\Phi$ 49.8x12.48Model KTR-2493:48.8x48.8x12.42;Model KTR-2494:48.8x48.8x12.45;	SimilarNote 5
Housing Materials andConstruction	ABS plastic	Silicone & ABS	Main unit: ABS plastic	Same
Function and Design	Electrical stimulation	Electrical stimulation andheat	Not public available	SimilarNote 1
Waveform	Biphasic	Biphasic	Pulsed, symmetric,biphasic	Same
Shape	Rectangular	Rectangular	Rectangular, withinterphase interval	Same
Maximum output voltageat 500Ω	45 V ±10%	PL-029K5BL:65 ±20%PL-025K15: 36 ±20%PL-029T: 46 ±20%	43.6V±10% @ 500Ω	SimilarNote 3
Maximum OutputVoltage @ 2KΩ	80 V±10%	PL-029K5BL:132 ±20%PL-025K15: 72 ±20%PL-029T: 92 ±20%	59V±10% @ 2KΩ	SimilarNote 3
Maximum OutputVoltage @ 10KΩ	130V±10%	PL-029K5BL:180 ±20%PL-025K15: 125 ±20%PL-029T: 136 ±20%	66.5V±10% @ 10KΩ	SimilarNote 3
Maximum OutputCurrent @ 500Ω	90 mA ±10%	PL-029K5BL:130±20%PL-025K15: 72 ±20%	87.2mA±10% @500Ω	SimilarNote 3
		PL-029T: 92±20%
Maximum OutputCurrent @ 2KΩ	40mA±10%	PL-029K5BL:66 ±20%PL-025K15: 36 ±20%PL-029T: 47 ±20%	29.5mA±10% @ 2KΩ	SimilarNote 3
Maximum OutputCurrent @ 10KΩ	13mA±10%	PL-029K5BL:18±20%PL-025K15: 12.5 ±20%PL-029T: 13.6 ±20%	6.65mA±10% @10KΩ	SimilarNote 3
Pulse Width (µSec)	107	PL-029K5BL: 50~500PL-029K15: 100PL-029T: 104	120µs	SimilarNote 3
Pulse period (mSec)	10~28.57	PL-029K5BL: 2~~1000PL-029K15: 10~~1000PL-029T: 6~833	Not public available	SimilarNote 3
Frequency (Hz)	35-100	PL-029K5BL: 1~~500PL-029K15: 1~~100PL-029T: 1.2~167	20-100Hz	SimilarNote 3
Maximum Phase charge(µC) at 500Ω	9.6	PL-029K5BL:78PL-025K15: 14.5PL-029T: 19.3	12.66µC @ 500Ω	SimilarNote 3
Maximum averagecurrent density (mA/cm²) at 500Ω	1.70	PL-029K5BL: 1.86PL-029K15: 0.35PL-029T: 0.40	0.058 (mA/cm²)	SimilarNote 3
Maximum averagepower density (mW/cm²) at 500Ω	0.035	PL-029K5BL: 28PL-029K15: 1.68PL-029T: 2.22	0.037 (mW/cm²)	DifferentNote 3
On time (sec)	Mode 1: 10Mode 2: 5	1~20	Not public available	SimilarNote 6
Off time (sec)	Mode 1: 7Mode 2: 1.3	0~10	Not public available	SimilarNote 6
Electrode area	53cm²	Not public available	Not public available	DifferentNote 7

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Comparison in Detail(s):

Note 1:

The intended use of the subject device is the same as the primary predicate device K191151 and include the intended use of reference device K200237. But the Indication for use (IFU) differs slightly because the predicate 1 includes the heating function. So, the product code IRT is not included in this submission. The intended use for OTC and Prescription use is the same as the primary predicate device K191151. The difference does not have effect on the intended use.

Note 2:

The applied part of subject device is type BF, according to Table 3 of IEC 60601-1: 2020, the allowable values of patient leakage current under normal condition is less than 10 µA (d.c. current) and less than 10 50 µA under single fault condition (d.c. current). So, the subject device meets the requirement of IEC 60601-1. This difference will not raise safety issue.

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Note 3:

The parameter of subject device is very close to the predicates:

Maximum output voltage at 500Ω is close to primary predicate device K191151 and reference device । K200237;
-Maximum Output Voltage at 2KΩ, Maximum Output Voltage at 10KΩ, Pulse Width (μSec) and Maximum average current density (mA/cm2) at 500Ω are close to the primary predicate device K191151;
The pulse width as well as frequency are within the range of PL-029T of primary predicate device -K191151.
Maximum average power density (mW/cm²) at 500Ω is close to the reference device K200237; -

So, we think that the difference will not raise safety or effectiveness issue.

Note 4:

The "Time range" of subject device is 30 minutes, within the range of predicate device (10~~60 min, or 10~~540 min). And other performance parameter such as maximum output voltage and maximum output current are almost the same as the predicate device. So, the difference will not raise any safety or effectiveness issue.

Note 5:

Although the "Weight" and "Dimensions" are different from the predicate devices, the appearance will not have effect on the safety and effectiveness.

So, the difference will not raise any safety or effectiveness issue.

Note 6:

Although the "On time" and "Off time" are different from the predicate devices, but other performance parameter such as maximum output voltage and maximum output current are almost the same as the predicate devices. And the device meets the requirement of IEC 60601-2-10, so these differences will not raise any safety or effectiveness issue.

Note 7:

Though the electrode area of subject device may be different from that of predicate, but the result of Maximum average current density (mA/cm2) at 500Ω is close to primary predicate device K191151. And Maximum average power density (mW/cm2) at 500Ω is close to reference device K200237, and meet the requirement of FDA guidance "Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA reviewers/Staff and Compliance". So, the difference will not raise safety and effective issues.

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8. Test Summary

8.1 Summary of Non-Clinical Performance Testing

1) Performance Testing Summary

The ManaFlexx2 (Model: MF002-OTC) has been evaluated the safety and performance by lab bench testing as following:

Title of the test	DeviceDescription/Samplesize	TestMethod/ApplicableStandards	AcceptanceCriteria	UnexpectedResults/SignificantDeviations	TestResult
Generalrequirements forbasic safety andessentialperformance	The testsample isthe final,finishedproduct.	ANSI AAMIES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl.AMD2:2021]	The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard.	NA	Pass
Electromagneticdisturbances	The testsample isthe final,finishedproduct.	IEC 60601-1-2 Edition4.1 2020-09	No degradationof performancewas foundduring test.	NA	Pass
Requirementsfor medicalelectricalequipment andmedicalelectricalsystems used inthe homehealthcareenvironment.	The testsample is thefinal, finishedproduct.	IEC 60601-1-11 Edition2.1 2020-07	The deviceoperatesnormally, andcan providebasic safetyand essentialperformance.	NA	Pass
Requirementsfor the basicsafety andessentialperformance ofnerve andmusclestimulators	The testsample isthe final,finishedproduct.	IEC 60101-2-10 Edition2.1 2016-04	The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard.	NA	Pass
Dispersion andShelf Life Test	The testsample is thefinal, finished	Measuringtheresistance	The impedancechange beforethe new and	NA	Pass
	product.	betweeneach pointin order toknow theevenlydistribute ofthe currentbased onthe ohm'sLaw.	agingelectrode, usedelectrodeshould notexceed ± 20%of the initialaverageimpedance.
Waveform&Output Test	The testsample is thefinal, finishedproduct.	UseElectricalLoad asload,connect tomatchedelectrodes.Then useoscilloscopeto test theoutputwaveform(voltage,frequency)between twoelectrodes.	According to "IEC60601-2-10,Particularrequirements forthe safety ofnerve and musclestimulators", thelimitation of outputparameters with500Ω resistanceload should meetthe followingrequirement:● The outputcurrent limitr.m.s. with500Ωresistanceload is 80mA● For pulsedurations ofless than0.1s, thepulse energywith 500Ωresistanceload shall notexceed300mJ perpulse.● The outputvoltage shallnot exceed apeak value of500V, whenmeasuredunder open-circuitcondition.	NA	Pass

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Otherwise,
the following
two
Acceptance
Criteria for
the device
according to
FDA
Guidance.
Maximum●
Power
Density <
0.25 (W/cm²)

2) Biocompatibility testing

The conductive hydrogel electrode of ManaFlexx 2 is identical to the SM Electrodes as it was cleared in K183154, 2019, in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents. Etc.).

3) Usability Testing

Usability testing was conducted on the ManaFlexx2, the device complies with IEC 62366-1 and IEC 60601-1-6.

4) Software verification and validation testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

5) Cybersecurity

The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.

6) Shelf-life testing

Shelf life testing was conducted to study the adhesion, conformability of the electrical outputs during its shelf-life, and the acceptable criteria of the testing is similar to K171722. The result show that the device can maintain it performance in 2 years.

8.2 Clinical Performance

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Clinical testing was not performed on the device.

9. Final Conclusion:

The subject device ManaFlexx2 has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K191151 and reference device K200237.

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).