FOCUS MODEL 795 UNIT

• K Number: K951951
• Device Name: FOCUS MODEL 795 UNIT
• Manufacturer: EMPI
• Date Cleared: 1996-05-17 ( 387 days)
• Product Code: GZJ GZI IPF
• Regulation Number: 882.5890

Intended Use

As a TENS device, the Focus is indicated for the following conditions: - symptomatic relief and management of chronic, intractable pain - . adjunctive treatment for post-surgical and post-trauma acute pain As a NMS/NMES device, the Focus is indicated for the following conditions: - relaxation of muscle spasm . - . prevention or retardation of disuse atrophy - . increasing local blood circulation - . muscle re-education - prevention of venous thrombosis of the calf muscles inmediately after surgery - maintaining or increasing range of motion As a FES device, the Focus is indicated for the following vondition: - stimulation of the muscles in the leg and ankle of part ally paralyzed patients to provide flexion of the foot and thus improve the patient's gait

Device Description

The Focus Unit is a dual channel NMES/TENS device with four conventional modes of operation, eight pre-programmed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform. The Focus Unit requires the use of a set of leadwires and one or two pair of electrodes. All NMES/TENS electrodes currently distributed by Empi are appropriate for use with the Focus. The use of other brands of electrodes is not recommended as the quality of those products is unknown and it has been observed that the quality of the clectrode may impact the ability of the Focus to operate efficiently, i.e., if the electrode does not adhere to the skin current will not be delivered.

Predicate Devices

Empi Focus Model 727, Empi Respond Select

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard TENS/NMES/FES device with conventional modes and pre-programmed regimens, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is indicated for various conditions related to pain relief, muscle function, and circulation, which are therapeutic purposes.

Diagnostic

No

The device description and indications for use clearly state its purpose for symptomatic relief, muscle-related therapies (TENS, NMS/NMES), and functional electrical stimulation (FES), all of which are therapeutic, not diagnostic. There is no mention of the device being used to identify or analyze a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "dual channel NMES/TENS device" and requires "leadwires and one or two pair of electrodes," indicating it is a hardware device that delivers electrical stimulation.

IVD (In Vitro Diagnostic)

Based on the provided text, 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 (like blood, urine, tissue) to detect diseases, conditions, or infections.
• Device Description and Intended Use: The description clearly states the device is a TENS/NMES/FES device. Its intended uses are related to pain management, muscle stimulation, and improving gait. These are all external applications of electrical stimulation to the body, not tests performed on samples taken from the body.

The device's function is to deliver electrical impulses to the body for therapeutic purposes, which is fundamentally different from the function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

As a TENS device, the Focus is indicated for the following conditions:

• symptomatic relief and management of chronic, intractable pain
• . adjunctive treatment for post-surgical and post-trauma acute pain

As a NMS/NMES device, the Focus is indicated for the following conditions:

• relaxation of muscle spasm .
• . prevention or retardation of disuse atrophy
• . increasing local blood circulation
• . muscle re-education
• prevention of venous thrombosis of the calf muscles inmediately after surgery
• maintaining or increasing range of motion

As a FES device, the Focus is indicated for the following vondition:

• stimulation of the muscles in the leg and ankle of part ally paralyzed patients to provide flexion of the foot and thus improve the patient's gait

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

Not Found

Device Description

The Focus Unit is a dual channel NMES/TENS device with four conventional modes of operation, eight pre-programmed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.

The Focus Unit requires the use of a set of leadwires and one or two pair of electrodes. All NMES/TENS electrodes currently distributed by Empi are appropriate for use with the Focus. The use of other brands of electrodes is not recommended as the quality of those products is unknown and it has been observed that the quality of the clectrode may impact the ability of the Focus to operate efficiently, i.e., if the electrode does not adhere to the skin current will not be delivered.

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

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)

Not Found

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.

Empi Focus Model 727, Empi Respond Select

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

§ 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).

Summary

0

K951951

MAY 17 1996 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

The assigned 510(k) number is: K951951

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant name:	Empi, Inc.
Applicant address:	5255 East River Rd.
	Fridley, MN 55421
Contact person:	Stacy Mattson, Regulatory Affairs Manager
Phone:	612-586-7354
Date Prepared:	August 21, 1995
Classification Name:	Transcutaneous Electrical Nerve Stimulator (TENS)
	Powered Muscle Stimulator (NMES)
	External Functional Neuromuscular Stimulator (FES)
Common/Usual Name:	NMES/TENS/FES unit
Trade/Proprietary Name:	Empi Focus
Equivalent Devices:	Empi Focus Model 727
	Empi Respond Select

Product Description:

The Focus Unit is a dual channel NMES/TENS device with four conventional modes of operation, eight pre-programmed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.

The Focus Unit requires the use of a set of leadwires and one or two pair of electrodes. All NMES/TENS electrodes currently distributed by Empi are appropriate for use with the Focus. The use of other brands of electrodes is not recommended as the quality of those products is unknown and it has been observed that the quality of the clectrode may impact the ability of the Focus to operate efficiently, i.e., if the electrode does not adhere to the skin current will not be delivered.

Intended Use:

As a TENS device, the Focus is indicated for the following conditions:

• symptomatic relief and management of chronic, intractable pain
• . adjunctive treatment for post-surgical and post-trauma acute pain

As a NMS/NMES device, the Focus is indicated for the following conditions:

• relaxation of muscle spasm .
• . prevention or retardation of disuse atrophy
• . increasing local blood circulation
• . muscle re-education
• prevention of venous thrombosis of the calf muscles inmediately after surgery
• maintaining or increasing range of motion

As a FES device, the Focus is indicated for the following vondition:

• stimulation of the muscles in the leg and ankle of part ally paralyzed patients to provide flexion of the foot and thus improve the patient's gait

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Comparison of Equivalent Devices to the New Device:

The Focus Model 795 is technically identical to the Focus 727 with the exception of a change in the LED lights from red to yellow. No testing is needed to establish equivalence.

The Focus Model 795 performs identically to the Focus 727 with the exception of an added function to prevent the stimulator from delivering current from a no output condition (no battery or device is turned OFF) to a rapid increase in current (fresh battery without turning the device OFF or manually turning the potentiometer up too quickly from start up of the device). This is an added "safety" feature which is required to meet international device standards. This function does not impact the performance of the device, thus does not require clinical testing to establish equivalence.

The Focus 795 also has a new indication for use, gait training, which makes the Focus indications for use equivalent to the indications for the Respond Select. This new indication is supported by the fact that these two products' specifications are similar enough to be considered equivalent. See the comparison chart for specification details.

Product Verification and Validation

The functional testing that was performed and analyzed ayainst product specifications demonstrates that the product meets requirements and is acceptable for its intended use.

Comparison of Product Specifications

See the following chart for details on the similarities and differences of the two predicate devices and the Focus device.

2

Product Characteristics	Vocis Model 728	Biphasic Model 795	Respond Select
No. Of Output Channels	2	2	2
Standards	AAMI/ANSI NS4-1985
IEC 601-2-10
IEC 601-1-2	AAMI/ANSI NS4-1985
IEC 601-2-10
IEC 601-1-2	AAMI/ANSI NS4-1985
IEC 601-2-10
IEC 601-1-2
Current Range	0-60mA (normal)
0-100mA (high)	0-60mA (normal)
0-100mA (high)	0-100 mA (alkaline)
0-90 mA (NiCd)
Maximum Output Voltage
(1kΩ load)	± 100 V *	± 100 V *	± 100 V*
Channel Interaction	≤ 5%	≤ 5%	≤ 5%
Pulse Width	300µs at 50% of peak amplitude	300µs at 50% of peak amplitude	300µs at 50% of peak amplitude
Waveforms *	Symmetrical biphasic or
balanced asymmetrical biphasic	Symmetrical biphasic or
balanced asymmetrical biphasic	Symmetrical biphasic or balanced
asymmetrical
biphasic
Zero Net DC	yes controlled by transformer	yes controlled by transformer	yes controlled by transformer
Maximum Phase Charge
(1kΩ load)	30µC *	30µC *	30µC *
Pulse Rates	25, 30, 35, 45, 50, 80 Hz	25, 30, 35, 45, 50, 80 Hz	1-80 Hz
ON Times	2.5, 5, 10, 15, 20, 25,
30, 50 sec	2.5, 5, 10, 15, 20, 25,
30, 50 sec	2-60 sec, adjustable
OFF Times	0, 5, 10, 15, 20, 25, 30,
50 sec	0, 5, 10, 15, 20, 25, 30,
50 sec	2-120 sec, adjustable
Ramp Time	2 sec up, fixed
2 sec down, fixed
disabled with remote switch	2 sec up, fixed
2 sec down, fixed
disabled with the remote switch	.2 - 10 sec up, adjustable
.1 - 5 sec down, adjustable
.4 sec up for gait protocol
1 sec down for gait protocol
Cycling Modes	synchronous(S) or alternating(A)	synchronous(S) or alternating(A)	synchronous or asynchronous
Timing Control Modes	continuous, normal operation, 15
or 30min,	continuous, normal operation,
15 or 30min,	continuous, 15, 30, 60min.
Preprogrammed Regimens	8	8	4
High Output Shutdown
(Output Interlock)	NO	YES	YES
Waveform Change Interlock	YES	YES	YES
Compliance Timer	NO	NO	YES
Accessories	Hand Held Remote or
Heel Switch	Hand Held Remote or
Heel Switch	Hand Held Remote or
Heel Switch
Output Type	constant current
100Ω - 1kΩ	constant current
100Ω - 1kΩ	constant current
100Ω - 1kΩ
Minimum Electrode Size	Snapease: 0.79in²(5.1cm²)	Snapease: 0.79in²(5.1cm²)	Snapease: 0.79in²(5.1cm²)
Maximum RMS Current
Density	27.7mA/in² *	27.7mA/in² *	27.7mA/in² *
Maximum Phase Amplitude
(specify load)	100mA at 1kΩ *	100mA at 1kΩ*	100mA at 1kΩ*
Maximum Power Density	607 mW/in² *	607 mW/in² *	607 mW/in² *
Product Characteristics	Focus Model 727	Focus Model 795	Respond Select
Phase Duration Range	300 µsec	300 µsec	300 µsec
Interface Interval	500 µsec	500 µsec	30 µsec
Maximum Enclosure
Leakage Current	100μΑ	100μΑ	100μΑ
Automatic Overload Trip	NA	NA	NA
Automatic No Load Trip	NA	NA	NA
Patient Override Control	NA	NA	NA
Max. Patient Leakage Current	100μΑ	100μΑ	100μΑ
Output Indicator	YES	YES	YES
Low Battery Indicator	YES	YES	YES
Size	3.7x2.5x0.84	3.7x2.5x0.84	6x3.58x1.38
Weight	145 gm with battery	145 gm with battery	9.3 oz w/o battery
Power Source	9 V Alkaline Battery	9 V Alkaline Battery	9 V Alkaline Battery
Controller	Microprocessor, masked	Microprocessor, masked	Application Specific Integrated
Circuit
Housing Material	ABS Plastic	ABS Plastic	ABS Plastic
Indications for Use	As a TENS device, the 727 is
indicated for the following
conditions:
• symptomatic relief and
management of chronic,
intractable pain
• adjunctive treatment for
post-surgical and post-
trauma acute pain
As a NMS/NMES device, the
Focus is indicated for the
following conditions:
• relaxation of muscle spasm
• 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	As a TENS device, the 795 is
indicated for the following
conditions:
• symptomatic relief and
management of chronic,
intractable pain
• adjunctive treatment for
post-surgical and post-
trauma acute pain
As a NMS/NMES device, the
Focus is indicated for the
following conditions:
• relaxation of muscle spasm
• 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
As a FES device, the Focus is
indicated for the following
condition:
• stimulation of the muscles
in the leg and ankle of
partially paralyzed patients
to provide flexion of the
foot and thus improve the
patient's gait	As a NMS/NMES device,
Respond Select is indicated
for the following conditions:
• relaxation of muscle spasm
• 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
As a FES device, the Focus is
indicated for the following
condition:
• stimulation of the muscles
in the leg and ankle of
partially paralyzed patients
to provide flexion of the
foot and thus improve the
patient's gait

COMPARISON OF PRODUCT SPECIFICATIONS

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COMPARISON OF PRODUCT SPECIFICATIONS (cont.)