Predicate Devices

Compex Sport Plus (K083140), Strive (K153704)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a microprocessor-controlled electrical stimulator with pre-defined programs selected by the user. There is no mention of the device learning or adapting based on data, which are key characteristics of AI/ML. The software validation focuses on meeting design requirements and cybersecurity, not on AI/ML performance.

Therapeutic

Yes
The device is intended for "Temporary relief of pain associated with sore and aching muscles" and "symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis," which are therapeutic claims.

Diagnostic

No

The device is described as an electrical stimulation device intended to stimulate muscles to improve performance (EMS) or for temporary pain relief (TENS). It generates electrical impulses and does not perform any diagnostic function (e.g., detecting, analyzing, or identifying a medical condition).

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a stimulator, lead wire set, electrodes, and a battery charger. While it mentions supporting software for the user interface, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for stimulating healthy muscles to improve performance (EMS) and for temporary pain relief (TENS). These are applications that involve direct interaction with the body for therapeutic or performance enhancement purposes.
Device Description: The description details how the device works by transmitting electrical impulses to stimulate nerves and muscles. This is a physical interaction with the body, not an in vitro (outside the living body) test.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers

The Compex Sport Elite is an electrical stimulation device intended for therapeutic and performance-related applications, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehabitable for rehabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:
· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

NGX, NUH, NYN

Device Description

The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex® Sport Elite system consists of these components:

1x Stimulator
1x Lead Wire Set
2x Small Performance Snap Electrode package
2x Large Performance Snap Electrode package
1x Battery Charger
These components are packaged together in a carrying case along with the user guide and a battery charger.

The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adults only.

Intended User / Care Setting

Over-The-Counter device

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)

Electrical Safety and Electromagnetic Compatibility: The Compex Sport Plus was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.

IEC 60601-1 for basic safety and essential performance
IEC 60601-1-2 for electromagnetic compatibility
IEC 60601-1-11 for use in a home healthcare environment
IEC 60601-2-10 for performance of nerve and muscle stimulators

Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements. DJO,LLC establish design inputs for the devices related to cybersecurity, and establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30(g).

Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.

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.

Compex Sport Plus (K083140), Strive (K153704)

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

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2017

DJO, LLC Neeta Sharma Sr. Director, Regulatory Affairs 1430 Decision Street Vista. California 92081

Re: K170918

Trade/Device Name: Compex Sport Elite Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: March 28, 2017 Received: March 29, 2017

Dear Neeta Sharma:

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. 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 801); medical device reporting (reporting of medical device-

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

1

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K170918

Device Name Compex Sport Elite

Indications for Use (Describe)

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:

· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is K170918.

| Submitted by: | DJO, LLC
1430 Decision Street
Vista, CA 92081
FDA Establishment Registration: 2020737 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neeta Sharma
Sr. Director, Regulatory Affairs
760-734-3551 |
| Date Summary Prepared: | June 19, 2017 |
| Trade Name: | Compex® Sport Elite |
| Classification Name: | Stimulator, muscle, powered (21 CFR 890.5850)
Stimulator, Nerve, Transcutaneous (21 CFR 882. 5890) |
| Product Code: | Powered Muscle Stimulator, For Muscle Conditioning – 21 CFR
890.5850; Product Code NGX; Review Panel: Physical Medicine
(primary product code) |
| | Stimulator, Nerve, Transcutaneous, Over-The-Counter- 21 CFR 882.5890;
Product Code NUH; Review Panel: Neurology |
| | Stimulator, Electrical, Transcutaneous, For Arthritis 21 CFR 890.5850;
Product Code NYN (subsequent code); Review Panel: Neurology |
| Regulatory Class: | Class II |
| Predicate Device: | Compex Sport Plus (K083140) - Class II
(primary predicate device)
Strive (K153704) - Class II |

Device Description:

The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the

4

parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex® Sport Elite system consists of these components:

1x Stimulator
1x Lead Wire Set
2x Small Performance Snap Electrode package ●
2x Large Performance Snap Electrode package
1x Battery Charger ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

Indications for Use:

The Compex Sport Elite EMS is used for:

The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The work imposed on the muscles by the Compex Sport Elite programs is definitely not suitable for rehabilitation and physiotherapy.

The Compex Sport Elite TENS is intended for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or ● normal household and work activities
The symptomatic relief and management of chronic, intractable pain and relief of pain ● associated with arthritis.

The Compex Sport Elite is an Over-the-Counter device to be used by adults only.

5

Comparison to the Predicate Device:

The indications for use for the Compex® Sport Elite are similar to those of the predicate devices, Compex Sport Plus (K083140) and Strive (K153704).

The technological characteristics of the predicate devices are very similar, but there are a few minor differences.

6

	Basic Unit Characteristics - Comparison with Predicate Device
	Characteristic	New Device	Predicate Device	Predicate Device	Similar/Different
1	510(k) Number	Pending	K083140	K153704
2	Device Name, Model	Compex Sport Elite	Compex Sport Plus	Strive
3	Manufacturer	DJO, LLC	DJO, LLC
510(k) sponsor:
Chattanooga
Group	DJO, LLC	Similar
4	Prescription/OTC	OTC	OTC	OTC	Similar
5	Type of device	A non-implantable,
battery powered, hand
held, electrical
stimulator, used for
medical purposes
through applying an
electrical current to
electrodes on a
patient's skin	A non-implantable,
battery powered, hand
held, electrical
stimulator, used for
medical purposes
through applying an
electrical current to
electrodes on a patient's
skin	A non-implantable,
battery powered, hand
held, electrical
stimulator, used for
medical purposes
through applying an
electrical current to
electrodes on a
patient's skin	Similar
6	Indications for Use	The Compex Sport
Elite EMS is used for:
The Compex Sport
Elite is intended to
stimulate healthy
muscles in order to
improve or facilitate
muscle performance.
The work imposed on
the muscles by the
Compex Sport Elite
programs is definitely	The Compex Sport
Elite is intended to
stimulate healthy
muscles in order to
improve or facilitate
muscle performance.
The Compex Sport Elite
is not intended for
adjunctive therapy in
the treatment of medical
diseases and conditions
of any kind. None of
the Compex Sport Elite	Over the Counter
Use: The Strive™
TENS device is
used for: -
temporary relief of
pain associated with
sore and aching
muscles due to
strain from exercise
or normal
household and work
activities. -the
symptomatic relief	NMES -Indication
for use are the same
as Compex Sport
Plus device
and
TENS-
Indication for use
are the same as
Strive
	not suitable for
rehabilitation and
physiotherapy.	stimulation programs are
designed for injured or
disease afflicted
muscles. Its use on such
muscles is
contraindicated. The
work imposed on the
muscles by the Compex
Sport Elite programs is
definitely not suitable
for rehabilitation and
physiotherapy.
The Compex Sport
Elite electrical
impulses allow the
triggering of action
potentials on
motoneurones of
motor nerves
(excitations).
These excitations of
motoneurones are
transmitted to the
muscle fibers via the
motor endplate where
they generate
mechanical muscle
fiber responses that
correspond to muscle
work.
Depending on the
parameters of the
electrical impulses
(pulse frequency	and management of
chronic, intractable
pain and relief of
pain associated with
arthritis.
	The Compex Sport
Elite TENS is intended
for:
• Temporary relief of
pain associated with
sore and aching
muscles due to
strain from exercise
or normal
household and work
activities
• The symptomatic
relief and
management of
chronic, intractable
pain and relief of
pain associated with
arthritis.
The Compex Sport
Elite is an Over-the-
Counter device to be
used by adults only.
			duration of
contraction, duration
of rest, total session
duration), different
types of muscle work
can be imposed on the
stimulated muscles.
The Compex Sport Elite
may therefore be
considered a technique
of muscle training.
7	Connection of device to
electrodes	Lead wires
With 6-pole cables
including female
custom SNAP
plugged on the
custom Compex
female SNAP
assembled in the
electrode. Entire
electronic circuit for
four (4) Stimulation
Channels and User
Interface is combined
into same casing,
connected to the
electrodes with 6-
pole cables.	Lead wires
With 6-pole cables
including female custom
SNAP plugged on the
custom Compex female
SNAP assembled in the
electrode. Entire
electronic circuit for
four (4) Stimulation
Channels and User
Interface is combined
into same casing,
connected to the
electrodes with 6-pole
cables.	Lead wires	Similar
8	Power Sources	Rechargeable Ni-Mh
Battery 4.8V (4 cells
AA=R6)	Rechargeable Ni-Mh
Battery 4.8V (4 cells
AA=R6)	LiPo 250 [mAh]
(3.7[V]), not removable	Same as Compex
Sport Plus
Different from
Strive
	Method of line current
isolation	N/A (battery operated
device)	N/A (battery
operated device)	N/A (battery operated
device)	Similar
Patient Leakage Current		N/A (battery operated device)	N/A (battery operated device)	N/A (battery operated device)	Similar
	• Normal condition	N/A (battery operated device)	N/A (battery operated device)	N/A (battery operated device)	Similar
	• Single fault condition	N/A (battery operated device)	N/A (battery operated device)	N/A (battery operated device)	Similar
9	Number of Output Modes	Two (NMES/TENS)	One (NMES)	Two (2 x TENS)	Different
10	Number of Output Channels	Four	Four	1, split	Same as Compex
Sport Plus
Different from
Strive
	Synchronous or Alternating?	Synchronous, but never 2 channels activated at the same time	Synchronous, but never 2 channels activated at the same time	N/A	Same as Compex
Sport Plus
Different from
Strive
	Method of Channel Isolation	Each channel is the middle of a H-Bridge. Except when it is activated, each channel is always in high impedance state.	Each channel is the middle of a H- Bridge. Except when it is activated, each channel is always in high impedance state.	N/A	Same as Compex
Sport Plus
Different from
Strive
11	Regulated Current or Regulated Voltage?	Regulated current (all channels)	Regulated current (all channels)	Regulated Current	Similar
12	Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Similar
13	Automatic Overload Trip?	Yes	Yes	No	Same as Compex
Sport Plus
Different from
Strive
14	Automatic No-Load Trip?	Yes	Yes	Yes	Similar
15	Automatic Shut Off?	"On/Off" switch	"On/Off" switch	"On/Off" switch	Similar
ા ર
17	Patient Override Control?
Indicator Display	Yes	Yes	No	Same as Compex
Sport Plus
Different from
Strive
Similar
	On/Off Status?
।	Yes	Yes	Yes
	Low Battery?

                                                                                                                                                                                                                                                                                                                                                                                                                                 | Yes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Yes                                                                                                                                                                                                                                                                                                                                                                                          | No                                                                                                                                                                                                                                                             | Same as Compex

Resistance
Strength
Explosive Strength
Potentiation
Training Recovery
(same as Active
Recovery)
Competition
Recovery (same as
Recovery Plus)
Pre-Warmup
Program
Muscle Relaxation
(same as Massage)
-Pain relief TENS
(same as FM) | - Endurance
Resistance
Strength
Explosive Strength
Potentiation
Active Recovery
Recovery Plus
Pre-Warmup
Massage | Frequency Modulation
(FM) and SMP | Different |
| 25 | Electrodes | Article number :
11-9119
11-9120 | Article number :
11-9119
11-9120 | Article number:
6250900 | Same as Sport Plus
Different from
Strive |
| | Output Specifications – Comparison with Predicate Device | | | | |
| | Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| 1 | 510(k) Number | Pending | K083140 | K153704 | |
| 2 | Device Name, Model | Compex Sport Elite | Compex Sport Plus | Strive | |
| 3 | Manufacturer | DJO, LLC | DJO, LLC
510(k) sponsor:
Chattanooga Group | DJO, LLC | Similar |
| 4 | Waveform (program per
program) | -Endurance:
Symmetrical Biphasic
-Resistance:
Symmetrical Biphasic
-Strength :
Symmetrical Biphasic
-Explosive Strength:
Symmetrical Biphasic
-Potentiation:
Symmetrical Biphasic
-Training Recovery
(same as Active
Recovery):
Symmetrical Biphasic
-Competition
Recovery (same as
Recovery Plus):
Symmetrical
Biphasic
-Pre-Warmup
Program: Symmetrical | -Endurance:
Symmetrical Biphasic
-Resistance:
Symmetrical Biphasic
-Strength : Symmetrical
Biphasic
-Explosive Strength:
Symmetrical Biphasic
-Potentiation:
Symmetrical Biphasic
-Active Recovery:
Symmetrical Biphasic
-Recovery Plus:
Symmetrical
Biphasic
-Pre-Warmup Program:
Symmetrical Biphasic
-Massage: Symmetrical
Biphasic | | Same as
Compex Sport
Plus
Different from
Strive |
| | Biphasic
-Muscle Relaxation
(same as Massage):
Symmetrical Biphasic

-Pain relief TENS
(same as FM):
Balanced, asymetrical
Biphasic | | Balanced, Asymmetrical
Biphasic | Same as Strive
Different from
Compex Sport
Plus | |
| 5
Shape (program per program) | -Endurance:
Rectangular
-Resistance:
Rectangular
-Strength :
Rectangular
-Explosive Strength:
Rectangular
-Potentiation:
Rectangular
-Training Recovery
(same as Active
Recovery):
Rectangular
-Competition
Recovery (same as
Recovery Plus):
Rectangular
-Pre-Warmup
Program: Rectangular
-Muscle Relaxation
(same as Massage):
Rectangular | -Endurance: Rectangular
-Resistance: Rectangular
-Strength : Rectangular
-Explosive Strength:
Rectangular
-Potentiation:
Rectangular
-Active Recovery:
Rectangular
-Recovery Plus:
Rectangular
-Pre-Warmup Program:
Rectangular

Massage: Rectangular | Square positive pulse,
current controlled
Logarithmic negative | Same as
Compex Sport
Plus
Different from
Strive | |
| | | | | Different from | |
| | | -Pain relief TENS
(same as FM): | | Compex Sport
Plus | |
| 6 | Maximum Output Voltage (± 10%) | Endurance:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Endurance:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Resistance:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Resistance:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Strength:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Strength:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Explosive Strength:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Explosive Strength:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Potentiation:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Potentiation:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Training Recovery:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Training Recovery:
60 V @ 500 Ω
165 V @ 2 ΚΩ
165 V @ 10 ΚΩ | Same as
Compex Sport
Plus
Different from
Strive | |

Device Comparison Tables

7

8

9

10

11

12

13

14

15

| Competition
Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ

Pre Warmup
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ

Muscle Relaxation:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ

Pain Relief TENS:
165[V] peak on
10[kΩ]
152[V] peak on 2[kΩ]
60[V] peak on 500[Ω] | Competition Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ

Pre Warmup
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ

Muscle Relaxation:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | 110[V] peak on 10[kΩ]
110[V] peak on 2[kΩ]
30[V] peak on 500[Ω] | Same as
Compex Sport
Plus
Different from
Strive

Same as
Compex Sport
Plus
Different from
Strive

Different from
Strive and from
Compex Sport
Plus |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

16

7	Maximum Output Current (± 10%)	Endurance:	Endurance:	Same as
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Compex Sport
Plus
Different from
Strive
		Resistance:	Resistance:
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Same as
Compex Sport
Plus
Different from
Strive
		Strength:	Strength:
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Same as
Compex Sport
Plus
Different from
Strive
		Explosive Strength:	Explosive Strength:
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Same as
Compex Sport
Plus
Different from
Strive
		Potentiation:	Potentiation:
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Same as
Compex Sport
Plus
Different from
Strive
		Training Recovery:	Training Recovery:
		120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Same as
Compex Sport
Plus
Different from
Strive
		Competition
Recovery:	Competition Recovery:	Same as
		120 mA @ 500 Ω
82 mA @ 2 kΩ	120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	Compex Sport
Plus
8	Pulse Width	16 mA @ 10 kΩ
Pre Warmup
120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ
Muscle Relaxation:
120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ
Pain Relief TENS:
12[mA] peak
@10[kΩ]
76[mA] peak@2[kΩ]
119[mA]
peak@500[Ω]	Pre Warmup
120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ
Muscle Relaxation:
120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ	12[mA] peak @10[kΩ]
55[mA] peak@2[kΩ]
60[mA] peak@500[Ω]	Different from
Strive
Same as
Compex Sport
Plus
Different from
Strive
Same as
Compex Sport
Plus
Different from
Strive
Same as
Compex Sport
Plus
Different from
Strive
					Different from
Strive and from
Compex Sport
Plus
		Endurance:
200 to 400 [μs]	Endurance:
200 to 400 [μs]		Same as
Compex Sport
Plus
		Resistance:
200 to 400 [μs]	Resistance:
200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Strength:	Strength:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Explosive Strength:	Explosive Strength:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Potentiation:	Potentiation:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Training Recovery:	Training Recovery:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Competition
Recovery:	Competition Recovery:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Pre Warmup	Pre Warmup
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Muscle Relaxation:	Muscle Relaxation:
	200 to 400 [μs]	200 to 400 [μs]		Different from
Strive
Same as
Compex Sport
Plus
	Pain Relief TENS:
70 to 300[μs]
(measured at 50% of
positive pulse)		70 to 300[μs] (measured at
50% of positive pulse)	Different from
Strive

				Same as
Compex Sport
Plus
Different from
Strive
				Same as Strive,
different from
Compex Sport
Plus
9	Frequency	Endurance:
10 [Hz]	Endurance:
10 [Hz]	Same as
Compex Sport
Plus
Different from
Strive
		Resistance:
50 [Hz]	Resistance:
50 [Hz]
		Strength:
75 [Hz]	Strength:
75 [Hz]
		Explosive Strength:
100 [Hz]
Potentiation:
From 1 to 75 [Hz]	Explosive Strength:
100 [Hz]
Potentiation:
From 1 to 75 [Hz]
		Training Recovery:
10 [Hz]	Training Recovery:
10 [Hz]
		Competition
Recovery:
0.5 [Hz]	Competition Recovery:
0.5 [Hz]
		Pre Warmup	Pre Warmup
4 [Hz]
		4 [Hz]
Muscle Relaxation:
1 [Hz]

Beat Frequency [Hz] | N/A | N/A | N/A | Similar |
| 11 | For multiphasic waveforms
only:
Symmetrical phases?
Phase Duration (include units)
(state range, if applicable)
(both phases, if asymmetrical) | Endurance:
Symmetrical, 280 -
400 μs

Resistance:
Symmetrical, 280 -
400 μs

Strength:
Symmetrical, 280 -
400 μs

Explosive Strength:
Symmetrical, 280 -
400 μs | Endurance:
Symmetrical, 280 - 400
μs

Resistance:
Symmetrical, 280 - 400
μs

Strength:
Symmetrical, 280 - 400
μs

Asymmetrical
70 to 300[µs] for positive
pulse, logarithmic negative
pulse, decrease current. | | |
| | Symmetrical, 70 -
300 µs | | | | |
| 12 | Net Charge [µC/pulse] | | | | |
| | | Endurance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Endurance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Different from
Compex Sport
Plus and Strive | |
| | | Resistance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Resistance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Explosive Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Explosive Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Same as
Compex Sport
Plus
Different from
Strive | |
| | | Potentiation:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Potentiation:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Same as
Compex Sport
Plus
Different from
Strive | |

17

18

19

20

21

22

23

| Training Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | Training Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex Sport
Plus
Different from
Strive |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------|-------------------------------------------------------------|
| Competition
Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | Competition Recovery:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex Sport
Plus
Different from
Strive |
| Pre Warmup
0 [μC] @ 500Ω
Excitation pulse fully
compensated | Pre Warmup
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex Sport
Plus
Different from
Strive |
| Muscle Relaxation:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | Muscle Relaxation:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex Sport
Plus
Different from
Strive |
| Pain Relief TENS:
0 [μC] @ 500Ω
Excitation pulse fully
compensated | | 18[uC] on 1[kΩ] | |

24

| | | | | | Different from
Compex Sport
Plus and Strive |
|----|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------|
| 13 | Maximum Phase Charge [µC] | 48 [µC] @ 500Ω | 48 [µC] @ 500Ω | 0[uC] on 1[kΩ] | Same as
Compex Sport
Plus
Different from
Strive |
| 14 | Maximum Current Density
[mA/cm²] | 4.8 [mA/cm²] @
500Ω | 4.8 [mA/cm²] @ 500Ω | 0.31[mA/cm2] (over 1[s]
period) | Same as
Compex Sport
Plus
Different from
Strive |
| 15 | Maximum Power Density
[mW/cm²] | 27.6 [mW/cm²] @
500Ω | 27.6 [mW/cm²] @
500Ω | 4.92[mW/cm2]
(split on 2x1[ΚΩ] in //) | Same as
Compex Sport
Plus
Different from
Strive |
| 16 | Burst Mode (i.e. pulse trains)
a) Pulses per burst
b) Bursts per second
c) Burst duration (seconds)
Duty Cycle [Line (b) x Line
(c)] | N/A, no burst mode | N/A, no burst mode | N/A, no burst mode | Similar |
| 17 | ON Time (seconds) | Depends on the
selected program | Depends on the
selected program | Once started, the output is
active until user manually
stops the unit | Same as
Compex Sport
Plus
Different from
Strive |
| 18 | OFF Time (seconds) | Depends on the
selected program | Depends on the
selected program | N/A, no OFF time | Same as
Compex Sport
Plus
Different from
Strive |
| 19 | Additional Features (if
applicable) | N/A | N/A | N/A | Similar |

25

Although there are minor differences observed between the subject devices, those differences do not raise any question in regards to safety and effectiveness.

26

Performance Testing:

Electrical Safety and Electromagnetic Compatibility: The Compex Sport Plus was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.

IEC 60601-1 for basic safety and essential performance ●
IEC 60601-1-2 for electromagnetic compatibility
IEC 60601-1-11 for use in a home healthcare environment ●
IEC 60601-2-10 for performance of nerve and muscle stimulators ●

Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements. DJO,LLC establish design inputs for the devices related to cybersecurity, and establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis that is required by 21 CFR 820.30(g).

Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.

Standards:

The Compex Sport Plus conforms to the following standards:

. AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.). FDA Recognition No. 19-4.
. IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1 -2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. FDA Recognition No. 19-1.
. IEC 60601-1-6 Edition 3.1 2013-10. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability. FDA Recognition No. 5-89.
. IEC 60601-1-11 Edition 2.0 2015-01. 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 . (General II (ES/EMC)). FDA Recognition No. 19-14.
. IEC 60601-2-10 Edition 2.0 2012-06. Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators. FDA Recognition No. 17-11.
. IEC 62366 Edition 1.1 2014-01 , Consolidated Version Medical Devices - Application Of Usability Engineering To Medical Devices. (General I (OS/RM)). FDA Recognition No. 5-87

27

ISO 14971 Second Edition 2007-03-01. Medical Devices Applications of Risk Management to Medical . Devices. FDA Recognition No. 5-40.
AAMI /ANSI /IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. FDA Recognition No. 13-32.

This submission does not contain clinical data.

Conclusion:

Based on the performance testing and the technological characteristics, it can be concluded that the Compex Sport Elite is as safe and effective as, and substantially equivalent to, the predicate devices.