Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that adapt or learn from data. The device description focuses on standard TENS and NMES principles and electrical stimulation programs.

Therapeutic

Yes.
The device is used for pain relief, muscle stimulation for therapeutic purposes (e.g., preventing disuse atrophy, increasing local blood circulation, muscle re-education), and managing post-surgical/post-traumatic pain, which are all therapeutic applications.

Diagnostic

No

The device is a nerve and muscle stimulator used for therapeutic purposes like pain relief and muscle performance improvement, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Nerve and Muscle Stimulator (model: XFT-2000)" and is "powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode." This indicates it is a physical hardware device that delivers electrical stimulation, not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The XFT-2000 is a Nerve and Muscle Stimulator that applies electrical stimulation to the body's surface. It does not analyze samples taken from the body.
Intended Use: The intended uses described are all related to applying electrical stimulation for pain relief, muscle stimulation, and improving circulation. None of these involve testing biological samples.
Device Description: The description clearly states it's based on neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) principles, which are external stimulation methods.

Therefore, based on the provided information, the XFT-2000 falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]:

XFT-2000 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.

XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.

Prescription Use:
XFT-2000 is intended for the following use:

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
Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Product codes (comma separated list FDA assigned to the subject device)

IPF, GZJ

Device Description

Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems.

Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode.

The device is for both prescription and over the counter. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

muscles in the arms, abdomen, legs, and buttocks, calf muscles of lower extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 subject device conforms to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General IEC Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

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 Healthcare Environment

IEC 60601-2-10:2016 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.

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.

K082011, K162517

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.

K132588, K153704, K171803, K130802

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

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).

Summary

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.

April 11, 2020

Shenzhen XFT Medical Limited % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122#, International Mayors Communication Centre NO. 55 Shizhou middl Shenzhen, Guangdong, China Re: K193275 Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: January 6, 2020 Received: January 13, 2020

Dear Field Fu:

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 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

1

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 medical devices and radiation-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,

For Vivek Pinto, PhD Director 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) K193275

Device Name Nerve and Muscle Stimulator

Indications for Use (Describe) Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]:

XFT-2000 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.

XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.

Prescription Use:

XFT-2000 is intended for the following use:

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
Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

5.1 Administrative Information

| Date of Summary

prepared	Oct. 23, 2019
Manufacturer
information	Company title: Shenzhen XFT Medical Limited.
	Company address:
Room 203, Building 1, Biomedicine Innovations
Industrial Park, #14 Jinhui Road, Pingshan New
District, Shenzhen, China.
Contact person: Cindy Peng
Phone: +86 755 29888818
	Fax: +86-0755-28312625
	E-mail: xftrs2@xft.cn
Submission
Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
Address: 1713A, 17th Floor, Block A,
Zhongguan Times Square, Liuxian Avenue, Xili
	Town, Nanshan District, Shenzhen, Guangdong
Province, China.
	Contact person: Mr. Field Fu
Image: logo	E-Mail: field@cefda.com;
Establishment
registration number

5.2 Device Information

| Type of 510(k)

submission:	Traditional
Trade Name:	Nerve and Muscle Stimulator
Model:	XFT-2000
	Stimulator, Muscle, Powered;
Classification
name:	Stimulator, Nerve,
	Transcutaneous, For Pain Relief.

5

Review Panel:	Physical Medicine; Neurology.
Product Code:	IPF; GZJ.
Device Class:	II
Regulation Number:	890.5850; 882.5890.

5.3 Predicate Device Information

Sponsor:	Rio-Medical Research Ltd.
Device:	MediStim XP, Type 281;
510(K) Number:	K082011
Sponsor:	JKH Health Co., Ltd.
Device:	Electronic Pulse Stimulator
510(K) Number:	K162517

5.4 Device Description

Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems.

Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode.

The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

5.5 Intended Use/ Indications for Use

Over-The-Counter Use:

TENS[ (Program 1~9, Program 15 (Frequency15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

6

XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 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.

XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.

Prescription Use:

XFT-2000 is intended for the following use:

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
Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

5.6 Technological characteristics of the subject device compared to the predicate device

See next pages.

7

| Elements of

Comparison	Subject Device	Predicate Device	Predicate Device	Remarks
510(k) Number	K193275	K082011	K162517
Manufacturer	Shenzhen XFT
Medical Limited	Rio-Medical
Research Ltd	JKH USA, LLC
Device
type/model	XFT-2000	Medistim XP Type 281;	PL-029K12;	/
Intended use/
Indication
for
use	Neuromuscular
Electrical Stimulation
(NMES) for 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
and maintaining or
increasing range of
motion.
Transcutaneous
Electrical Nerve
Stimulation (TENS) for
an adjunctive
treatment in the
management of post-
surgical and post-
traumatic acute pain
problems.	Medistim XP delivers
stimulation based on the
principles of
Neuromuscular Electrical
NerveStimulation
(NMIES) and also
Transcutaneous
Electrical Nerve
Stimulation (TENS).
Theindications for use
are as follows:
Neuromuscular Electrical
Stimulation for relaxation
ofmuscle spasms,
prevention or retardation
of disuse atrophy,
increasing local blood
circulation,muscle re-
education, immediate
post-surgical stimulation
of calf muscles to
prevent venousthrombosis and
maintaining or increasing
range of motion.
Transcutaneous
Electrical
NerveStimulation
(TENS) for an adjunctive
treatment in the
management of post-
surgical and post-
traumatic acute pain
problems.	TENS (Modes 1, 2, 4,
5, 6, 8):
To be 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.
It is also intended for
symptomatic relief and
management of
chronic, intractable
pain and relief of pain
associated with
arthritis.
PMS (also called EMS,
Modes 1, 3, 7):
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	SE
Elements of
Comparison	Subject Device	Predicate Device	Predicate Device	Remarks
			any medical conditions
or diseases.
t is also intended to
temporarily increase
local blood circulation
in the healthy muscles
of lower extremities.
Prescription
or
OTC	Prescription and OTC	Prescription	OTC	SE
Electrode	5cm round;K132588	5×5cm;7cm round;
5cm×9cm etc.
K970426,
K874469,K965194	unknown	SE
Waveform	Pulsed,Symmetrical
balanced biphasic
wave (rectangular)	Pulsed, Symmetrical
Biphasic, Rectangular
with interphase interval	Biphasic, Rectangular	SE
Performance	Compliance with IEC
60601-2-10	Compliance with IEC
60601-2-10	Compliance with IEC
60601-2-10	Same
Biocompatibility	All the patient
contacting materials
are compliance with
ISO 10993-1/-5/-10	All the patient contacting
materials are
compliance with ISO
10993-1/-5/-10	All the patient
contacting materials
are compliance with
ISO 10993-1/-5/-10	Same
Electrical Safety	Compliance with IEC
60601-1	Compliance with IEC
60601-1	Compliance with IEC
60601-1	Same
EMC	Compliance with IEC
60601-1-2	Compliance with IEC
60601-1-2	Compliance with IEC
60601-1-2	Same
Connecting
Safety	21CFR 898	21CFR 898	21CFR 898	Same
Parameter	Subject Device	Predicate Device	Predicate Device	Remarks
510(k) Number	K193275	K082011	K162517	/
Device Name and
Model	Nerve and Muscle
Stimulator, XFT-
2000	MediStimi XP, Type
281	JKH Stimulator:
PL-029K12,	/
Manufacturer	Shenzhen XFT
Medical Limited	Rio-Medical
Research Ltd	JKH USA, LLC	/
Power Source(s)	DC4.5V, 3 × AAA
batteries;
DC Adapter.	9V Battery (type
6LR61)	Rechargeable or
non-rechargeable
battery	Note 01
---Method of Line Current
Isolation	Battery Supply, or
DC Adapter	Battery Supply	Battery Supply	Note 01
---Patient Leakage Current:
Normal Condition (µA)	N/A	N/A	N/A	/
---Patient Leakage Current:
Single Fault Condition (µA)	N/A	N/A	N/A	/
Number of Output
Modes(programs)	15	9	8	Note 02
Number of Output Channels:	2	2	1	SE
---Synchronous or Alternating?	Both	Synchronous(Multip
lexed)	N/A	SE
---Method of Channel Isolation	Transistor	Transistor	N/A	SE
Regulated Current or
Regulated Voltage?	Regulated Current	Regulated Current	Regulated Voltage	SE
Software/Firmware/Microproce
ssor Control?	Yes	Yes	Yes	SE
Automatic Overload
Trip?	Yes	Yes	No	SE
Automatic No-Load Trip?	Yes	Yes	Yes	Same
Automatic Shut Off?	Yes	Yes	Yes	Same
Patient Override Control?	Yes, Pause button.	Yes, Pause button.	Yes	Same
Indicator
Display:	On/Off Status?	yes	yes	Yes	Same
	Low Battery?	yes	yes	Yes	Same
	Voltage/Current
Level?	Yes	yes	Yes	Same
Timer Range (minutes)	60mins	30mins--open	10-540mins;	SE
Compliance with Voluntary
Standards?	yes	yes	Yes	Same
Compliance with 21 CFR
898?	Yes	yes	Yes	Same
Weight	96g	93g (without battery)	25g	SE
Parameter	Subject Device	Predicate Device	Predicate Device	Remarks
		140g(with battery)
Dimensions (mm) [W x H x D]	114×66×20	105 x 71 x 31	69.5x36.8x14	SE
Housing Materials and
Construction	Silicone & ABS	not publicly available	Silicone & ABS	SE
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P1	P4	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
90.6V@ 2 kΩ
123V@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify units) (+/- 20%)	60.0mA@500Ω
45.3mA@ 2 kΩ
12.3mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration/width† (µsec)	250	300	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For multiphasic waveforms only:	Symmetrical phases?
Phase Duration† (include units), (state range, if applicable), (both phases, if asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (µC) per pulse) (If zero, state method of achieving zero net charge.)	15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)	15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Current Density,††(mA/cm2.)	0.46@500Ω	0.43@500Ω	3.26@500Ω
Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area)	0.0018@500Ω	0.0024@500Ω	0.00053@500Ω
Burst Mode (i.e., pulse trains):	(a) Pulses per burst 315 (Note 04)
(b) Bursts per second 0.11
(c) Burst duration (seconds) 9
(d) Duty Cycle: Line (b) x Line (c) 1	(a) Pulses per burst 245
(b) Bursts per second 0.14
(c) Burst duration (seconds) 7
(d) Duty Cycle: Line (b) x Line (c) 1	NA
ON Time (seconds)	9	7	3.4~20
OFF Time (seconds)	5	5	1~2.5
Additional Features (specify, if applicable)	N/A	N/A	N/A
Table 03-2:
Parameter		Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name		P2	P4	P7
Maximum Output Voltage (volts)
(+/-20%)		30.0V@500Ω
90.6V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)		60.0mA@500Ω
45.3mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration/width† (µsec)		250	300	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]		35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)		N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)		15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)		15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Current
Density,††(mA/cm2.)		0.46@500Ω	0.43@500Ω	3.26@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)		0.0018@500Ω	0.0023@500Ω	0.00053@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst
(b) Bursts per second
(c) Burst duration
(seconds)
(d) Duty Cycle: Line
(b) x Line (c)	490(Note 04)
0.07
14
1	245
0.14
7
1	NA
NA
NA
NA
ON Time (seconds)		14	7	3.4~20
OFF Time (seconds)		10	5	1~2.5
Additional Features (specify, if
applicable)		N/A	N/A	N/A
Table 03-3:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P3	P4	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
90.6V@ 2 kΩ
125Vpp@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify units) (+/- 20%)	60.0mA@500Ω
45.3mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration† (µsec)	250	300	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For multiphasic waveforms only:	Symmetrical phases?
Phase Duration† (include units),
(state range, if applicable),
(both phases, if asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC) per pulse) (If zero, state method of achieving zero net charge.)	15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)	15@500Ω	22.5@500Ω	16.3@500Ω
Maximum Current Density,††(mA/cm2.)	0.46@500Ω	0.43@500Ω	3.26@500Ω
Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area)	0.0018@500Ω	0.0024@500Ω	0.00053@500Ω
Burst Mode (i.e., pulse trains):	(a) Pulses per burst
(b) Bursts per second
(c) Burst duration (seconds)
(d) Duty Cycle: Line (b) x Line (c)	315(Note 04)
0.11
9
1	245
0.14
7
1	NA
NA
NA
NA
ON Time (seconds)	9	7	3.4~20
OFF Time (seconds)	5	5	1~2.5
Additional Features (specify, if applicable)	N/A	N/A	N/A
Table 03-4:
Parameter		Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name		P4	P1	P3
Maximum Output Voltage (volts)
(+/-20%)		30.0V@500Ω
90.6V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	47.6V@500Ω
96.0V@ 2 kΩ
132V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)		60.0mA@500Ω
45.3mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	95.2mA@500Ω
48.0mA@ 2 kΩ
13.2mA@10 kΩ
Pulse Duration/width† (µsec)		250	300	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]		60	50	12.8~54.3
For interferential modes only:
-Beat Frequency (Hz)		N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (µC)
per pulse) (If zero, state method of
achieving zero net charge.)		15@500Ω	22.5@500Ω	19.0@500Ω
Maximum Phase Charge, (µC)		15@500Ω	22.5@500Ω	19.0@500Ω
Maximum Current
Density,††(mA/cm2.)		0.60@500Ω	0.52@500Ω	2.64@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)		0.0031@500Ω	0.0034@500Ω	0.00032~0.00137@
500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst
(b) Bursts per second
(c) Burst duration
(seconds)
(d) Duty Cycle: Line
(b) x Line (c)	840(Note 04)
0.07
14
1	350
0.14
7
1	NA
NA
NA
NA
ON Time (seconds)		14	7	3.4~20
OFF Time (seconds)		10	5	1~2.5
Additional Features (specify, if
applicable)		N/A	N/A	N/A
Table 03-5:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P5	P3	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω	37.5V@500Ω
not publicly available	40.8V@500Ω
	90.6V@ 2 kΩ		86.4V@ 2 kΩ
	125V@10 kΩ	not publicly available	129V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	60.0mA@500Ω	75.0mA@500Ω
not publicly available	81.6mA@500Ω
	45.3mA@ 2 kΩ		43.2mA@ 2 kΩ
	12.5mA@10 kΩ	not publicly available	12.9mA@10 kΩ
Pulse Duration† (µsec)	300	300	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases? N/A	N/A	N/A
	Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)	18@500Ω	22.5@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)	18@500Ω	22.5@500Ω	16.3@500Ω
Maximum Current
Density,††(mA/cm2.)	0.50@500Ω	0.60@500Ω	3.26@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)	0.0022@500Ω	0.0045@500Ω	0.00053@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst 420(Note 04)	245	NA
	(b) Bursts per second 0.08	0.14	NA
	(c) Burst duration
(seconds) 12	7	NA
	(d) Duty Cycle: Line
(b) x Line (c) 1	1	NA
ON Time (seconds)	12	7	3.4~20
OFF Time (seconds)	8	5	1~2.5
Additional Features (specify, if
applicable)	N/A	N/A	N/A
Table 03-6:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P6	P7	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
90.6V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	60.0mA@500Ω
45.3mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration† (µsec)	350	350	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases? N/A
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)	21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)	21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Current
Density,††(mA/cm2.)	0.54@500Ω	0.47@500Ω	3.26@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)	0.0026@500Ω	0.0028@500Ω	0.00053@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst 315(Note 04)
(b) Bursts per second 0.11
(c) Burst duration
(seconds) 9
(d) Duty Cycle: Line
(b) x Line (c) 1	227
0.14
6.5
1	NA
NA
NA
NA
ON Time (seconds)	14	6.5	3.4~20
OFF Time (seconds)	10	5	1~2.5
Additional Features (specify, if
applicable)	N/A	N/A	N/A

Table 01: SE Comprehensive Comparison Table

8

9

Table 02: SE General Specification Comparison Table

10

Note 01: DC adaptor meets IEC 60601-1 standard.

Note 02: Number of Output Modes(programs) do not directly affect the affect safety and effectiveness of the subject device, for instance, the number of output modes for electrical stimulator model SEM44 (K171803) is respectively 35(EMS) and 15(TENS), and the number of output modes its predicate device model MT9001/LT3060 (K130802) is respectively 1(EMS) and 1(TENS). In addition, based on "Table 03: SE Detailed Comparison Table", P1, P2 , P3 of the subject device corresponds to P4 of K082011(type 281)and P7 of K162517 (PL-029K12); P4 corresponds to corresponds to P1 of K082011(type 281)and P3 of K162517 (PL-029K12), P5~P15 of the subject device corresponds also corresponds to one mode of K082011(type 281)and one mode of K162517 (PL-029K12). Also, according to the discussion in Note 03, Note 04, the difference between the parameters of mode of the subject device and the parameters of mode the predicate devices do not affect safety and effectiveness of the subject device, therefore, the difference of output mode number do not the determination of substantial equivalence.

11

Table 03: SE Detailed Comparison Table

Table 03-1:

12

13

14

15

16

17

Table 03-7:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P7	P7	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
89.1V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify units) (+/- 20%)	60.0mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration† (µsec)	350	350	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For multiphasic waveforms only:	Symmetrical phases? N/A
Phase Duration† (include units),
(state range, if applicable),
(both phases, if asymmetrical) N/A	N/A	N/A
Net Charge (microcoulombs (μC) per pulse) (If zero, state method of achieving zero net charge.)	21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)	21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Current Density,††(mA/cm2.)	0.54@500Ω	0.47@500Ω	3.26@500Ω
Maximum Power Density,†† (W/cm2), (using smallest electrode conductive surface area)	0.0026@500Ω	0.0028@500Ω	0.00053@500Ω
Burst Mode (i.e., pulse trains):	(a) Pulses per burst 490(Note 04)
(b) Bursts per second 0.07
(c) Burst duration (seconds) 14
(d) Duty Cycle: Line (b) x Line (c) 1	227
0.15
6.5
1	NA
NA
NA
NA
ON Time (seconds)	14	6.5	3.4~20
OFF Time (seconds)	10	5	1~2.5
Additional Features (specify, if applicable)	N/A	N/A	N/A
Table 03-8:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P8	P7	P7
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
89.1V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	40.8V@500Ω
86.4V@ 2 kΩ
129V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	60.0mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	81.6mA@500Ω
43.2mA@ 2 kΩ
12.9mA@10 kΩ
Pulse Duration† (µsec)	350	350	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	35	35	19.8
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?	N/A	N/A	N/A
	Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)		21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Phase Charge, (µC)		21@500Ω	26.25@500Ω	16.3@500Ω
Maximum Current
Density,††(mA/cm2.)		0.54@500Ω	0.47@500Ω	3.26@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)		0.0026@500Ω	0.0028@500Ω	0.00053@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst	315(Note 04)	227	NA
	(b) Bursts per second	0.11	0.15	NA
	(c) Burst duration
(seconds)	9	6.5	NA
	(d) Duty Cycle: Line
(b) x Line (c)	1	1	NA
ON Time (seconds)		9	6.5	3.4~20
OFF Time (seconds)		9	5	1~2.5
Additional Features (specify, if
applicable)		N/A	N/A	N/A
Table 03-9:		Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Parameter
Mode or Program Name		P9	P7	P3
Maximum Output Voltage (volts)
(+/-20%)		30.0V@500Ω	37.5V@500Ω	47.6V@500Ω
		90.6V@ 2 kΩ	not publicly
available	96.0V@ 2 kΩ
		125V@10 kΩ	not publicly
available	132V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)		60.0mA@500Ω	75.0mA@500Ω	95.2mA@500Ω
		45.3mA@ 2 kΩ	not publicly
available	48.0mA@ 2 kΩ
		12.5mA@10 kΩ	not publicly
available	13.2mA@10 kΩ
Pulse Duration† (µsec)		350	350	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]		60	35	12.8~54.3
For interferential modes only:
-Beat Frequency (Hz)		N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?
Phase Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
		N/A	N/A	N/A
Net Charge (microcoulombs (µC)
per pulse) (If zero, state method of
achieving zero net charge.)		21@500Ω	26.25@500Ω	19.0@500Ω
Maximum Phase Charge, (µC)		21@500Ω	26.25@500Ω	19.0@500Ω
Maximum Current
Density,‡‡(mA/cm2.)		0.71@500Ω	0.47@500Ω	2.64@500Ω
Maximum Power
Density,‡‡ (W/cm2), (using smallest
electrode conductive surface area)		0.0044@500Ω	0.0028@500Ω	0.00032~0.00137
@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst
(b) Bursts per second
(c) Burst duration
(seconds)
(d) Duty Cycle: Line
(b) x Line (c)	840(Note 04)
0.07
14
1	227
0.15
6.5
1	NA
NA
NA
NA
ON Time (seconds)		14	6.5	3.4~20
OFF Time (seconds)		10	5	1~2.5
Additional Features (specify, if
applicable)		N/A	N/A	N/A
Table 03-10:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P10	P8	P4
Maximum Output Voltage (volts)
(+/-20%)	30.0V@500Ω
89.1V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	57.6V@500Ω
93.6V@ 2 kΩ
108V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	60.0mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	115.2mA@500Ω
46.8mA@ 2 kΩ
10.8mA@10 kΩ
Pulse Duration† (µsec)	200	80	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	5	8	1.19
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases? N/A
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical) N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)	12@500Ω	6@500Ω	23.0@500Ω
Maximum Phase Charge, (µC)	12@500Ω	6@500Ω	23.0@500Ω
Maximum Current
Density,††(mA/cm2.)	0.16@500Ω	0.11@500Ω	3.20@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)	0.0002@500Ω	0.00014@500Ω	0.00004@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst 15(Note 04)
(b) Bursts per second 0.33
(c) Burst duration
(seconds) 3
(d) Duty Cycle: Line
(b) x Line (c) 1	52
0.15
6.5
1	NA
NA
NA
NA
ON Time (seconds)	3	6.5	3.4~20
OFF Time (seconds)	2	5	1~2.5
Additional Features (specify, if
applicable)	N/A	N/A	N/A
Table 03-11:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P11	P9	P4
Maximum Output Voltage (volts)
(+/-20%)	29.7V@500Ω
89.1V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	57.6V@500Ω
93.6V@ 2 kΩ
108V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	59.4mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	115.2mA@500Ω
46.8mA@ 2 kΩ
10.8mA@10 kΩ
Pulse Duration† (µsec)	200	150	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]	4	4~99	1.19
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases? N/A
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical) N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)	11.9@500Ω	11.25@500Ω	23.0@500Ω
Maximum Phase Charge, (μC)	11.9@500Ω	11.25@500Ω	23.0@500Ω
Maximum Current
Density,††(mA/cm2.)	0.14@500Ω	0.52@500Ω	3.20@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)	0.00016@500Ω	0.0033@500Ω	0.00004@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst N/A
(b) Bursts per second IN/A
(c) Burst duration
(seconds) N/A
(d) Duty Cycle: Line
(b) x Line (c) N/A	N/A	NA
ON Time (seconds)	Continuous	Continuous	3.4~20
OFF Time (seconds)	N/A	N/A	1~2.5
Additional Features (specify, if
applicable)	N/A	N/A	N/A
Table 03-12:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P12	P9	P5
Maximum Output Voltage (volts)
(+/-20%)	29.7V@500Ω
89.1V@ 2 kΩ
125V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	29.6V@500Ω
66.4V@ 2 kΩ
126V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	59.4mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	59.2mA@500Ω
33.2mA@ 2 kΩ
12.6mA@10 kΩ
Pulse Duration⁺ (µsec)	175	150	100 (Note 03)
Frequency⁺ (Hz) [or Rate⁺ (pps)]	125	4~99	104.1
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases? N/A
Phase
Duration⁺ (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical) N/A	N/A	N/A
Net Charge (microcoulombs (µC)
per pulse) (If zero, state method of
achieving zero net charge.)	10.4@500Ω	11.25@500Ω	11.8@500Ω
Maximum Phase Charge, (µC)	10.4@500Ω	11.25@500Ω	11.8@500Ω
Maximum Current
Density, ⁺⁺(mA/cm².)	0.72@500Ω	0.52@500Ω	1.64@500Ω
Maximum Power
Density,⁺⁺ (W/cm²), (using smallest
electrode conductive surface area)	0.0045@500Ω	0.0033@500Ω	0.00101@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst N/A
(b) Bursts per second N/A
(c) Burst duration
(seconds) N/A
(d) Duty Cycle: Line
(b) x Line (c) N/A	N/A	NA
ON Time (seconds)	Continuous	Continuous	3.4~20
OFF Time (seconds)	N/A	N/A	1~2.5
Additional Features (specify, if
applicable)	N/A	N/A	N/A
Table 03-13:	Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P13	P6	P6
Maximum Output Voltage (volts)
(+/-20%)	29.4V@500Ω
89.1V@ 2 kΩ
123V@10 kΩ	37.5V@500Ω
not publicly
available
not publicly
available	29.6V@500Ω
66.4V@ 2 kΩ
126V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)	58.8mA@500Ω
44.5mA@ 2 kΩ
12.3mA@10 kΩ	75.0mA@500Ω
not publicly
available
not publicly
available	59.2mA@500Ω
33.2mA@ 2 kΩ
12.6mA@10 kΩ
Pulse Duration+ (µsec)	150
250	300	100 (Note 03)
Frequency+ (Hz) [or Rate+ (pps)]	125
4	50
10	104.1
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?
Phase
Duration+ (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (µC)
per pulse) (If zero, state method of
achieving zero net charge.)	8.8@500Ω
14.7@500Ω	22.5@500Ω
22.5@500Ω	11.8@500Ω
Maximum Phase Charge, (µC)	8.8@500Ω
14.7@500Ω	22.5@500Ω
22.5@500Ω	11.8@500Ω
Maximum Current
Density,++(mA/cm2.)	0.66@500 Ω
0.15@500 Ω	0.52@500Ω
0.23@500Ω	1.64@500Ω
Maximum Power
Density,++ (W/cm2), (using smallest
electrode conductive surface area)	0.0038@500 Ω
0.0002@500 Ω	0.0034@500Ω
0.00068@500Ω	0.00101@500Ω
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst	N/A	N/A	NA
	(b) Bursts per second	N/A	N/A	NA
	(c) Burst duration
(seconds)	N/A	N/A	NA
	(d) Duty Cycle: Line
(b) x Line (c)	N/A	N/A	NA
ON Time (seconds)	Continuous	Continuous	3.4~20
OFF Time (seconds)	N/A	N/A	1~2.5
Table 03-14:
Parameter		Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name		P14	P9	P2
Maximum Output Voltage (volts)
(+/-20%)		29.4V@500Ω
90.6@ 2 kΩ
125Vpp@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	36.4V@500Ω
80.8V@ 2 kΩ
134V@10 kΩ
Maximum Output Current (specify
units) (+/- 20%)		58.8mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	72.8mA@500Ω
40.4mA@ 2 kΩ
13.4mA@10 kΩ
Pulse Duration† (µsec)		100	150	100 (Note 03)
Frequency† (Hz) [or Rate† (pps)]		50	4~99	62.5
For interferential modes only:
-Beat Frequency (Hz)		N/A	N/A	N/A
For
multiphasic
waveforms
only:	Symmetrical phases?	N/A	N/A	N/A
	Phase Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	N/A	N/A
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)		5.9@500Ω	11.25@500Ω	14.6@500Ω
Maximum Phase Charge, (µC)		5.9@500Ω	11.25@500Ω	14.6@500Ω
Maximum Current
Density,††(mA/cm2.)		0.34@500Ω	0.52@500Ω	2.02@500Ω
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)		0.001@500Ω	0.0033@500Ω	0.00092@500Ω
Burst Mode
(i.e., pulse trains):	(a) Pulses per
burst	N/A	N/A	NA
	(b) Bursts per
second	N/A	N/A	NA
	(c) Burst duration
(seconds)	N/A	N/A	NA
	(d) Duty Cycle:
Line (b) x Line (c)	N/A	N/A	NA
ON Time (seconds)		Continuous	Continuous	3.4~20
OFF Time (seconds)		N/A	N/A	1~2.5
Additional Features (specify, if
applicable)		N/A	N/A	N/A
Table 03-15:
Parameter	Subject Device
K193275	Predicate Device
K082011:
Type 281	Predicate Device
K162517:
PL-029K12
Mode or Program Name	P15	P9	P1 (Note 05)
Maximum Output Voltage (volts)
(+/-20%)	29.7V@500Ω
89.1V@ 2 kΩ
125Vpp@10 kΩ	37.5V@500Ω
not publicly available
not publicly available	/
Maximum Output Current (specify
units) (+/- 20%)	59.4mA@500Ω
44.5mA@ 2 kΩ
12.5mA@10 kΩ	75.0mA@500Ω
not publicly available
not publicly available	/
Pulse Duration† (µsec)	100~350	150	/
Frequency† (Hz) [or Rate† (pps)]	1~125	4~99	/
For interferential modes only:
-Beat Frequency (Hz)	N/A	N/A	/
For
multiphasic
waveforms
only:	Symmetrical phases? N/A
Phase
Duration† (include
units),
(state range, if
applicable),
(both phases, if
asymmetrical)	N/A	/
Net Charge (microcoulombs (μC)
per pulse) (If zero, state method of
achieving zero net charge.)	20.8@500Ω	11.25@500Ω	/
Maximum Phase Charge, (µC)	20.8@500Ω	11.25@500Ω	/
Maximum Current
Density,††(mA/cm2.)	1.02@500Ω	0.52@500Ω	/
Maximum Power
Density,†† (W/cm2), (using smallest
electrode conductive surface area)	0.0089@500Ω	0.0033@500Ω	/
Burst Mode
(i.e., pulse
trains):	(a) Pulses per burst 1~625
(b) Bursts per second 0.2~1
(c) Burst duration 1~5
(seconds)
(d) Duty Cycle: Line
(b) x Line (c) N/A	N/A	/
ON Time (seconds)	1~5	Continuous	/
OFF Time (seconds)	1~5	N/A	/
Additional Features (specify, if
applicable)	N/A	N/A	/

18

19

20

21

22

23

24

25

Note 03: based on K 153704, pulse width is acceptable within 70~300.

Note 04: subject device's pulses per burst rate is significantly higher than the predicate device in Table 03-1 to Table 03-9 and significantly less in Table 03-10, but the duty cycle of the subject device is same as the duty cycle of the predicate, so the differences do not affect safety and effectiveness of the subject device.

26

Note 05: based on K162517, Mode P1 cycles the mode 28, therefore, the maximum parameters do not appear at the same time. For example, in all 8 modes, the Maximum Output Voltage is 134V@10 kΩ, which is in mode P2 (K162517), but in mode P2, the corresponding Maximum Power Density is 0.92@500Ω , which is not maximum in all 8 modes. Nevertheless, the maximum parameters will not exceed the range of mode 28, similarly, P15 of subject device can be customized within the parameters of its P1-P14. So, P15 of subject device is SE to P1 of K162517 when P1,P2....P14 is respectively SE to mode P2,P3...P7.

5.7 Brief discussion of the nonclinical tests

The subject device conforms to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General IEC Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

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 Healthcare Environment

IEC 60601-2-10:2016 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators

ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.

5.8 Brief discussion of clinical tests N/A.

27

5.9 Other information (such as required by FDA guidance/Test) No.

5.10 Conclusions

The subject devices have all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject device is substantially equivalent to the predicate device.