The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

Device Description

SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter. The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector. The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.

AI/ML Overview

The NeuroMetrix SENSUS is a transcutaneous electrical nerve stimulator (TENS) intended for the symptomatic relief and management of chronic intractable pain.

Here's an analysis of its acceptance criteria and the study that proves its adherence, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NeuroMetrix SENSUS are primarily based on demonstrating substantial equivalence to a predicate device, the EMPI Active Transcutaneous Nerve Stimulator (K090922). This involves showing similar intended use, technological characteristics, and safety and effectiveness profiles. There are no explicit quantitative acceptance criteria for performance metrics in the provided document beyond being "within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators."

The device performance is reported by comparing its specifications to the predicate device.

Parameter	Acceptance Criteria (Substantial Equivalence to Predicate)	Reported Device Performance (NeuroMetrix SENSUS)	Predicate Device Performance (Empi Active Transcutaneous Nerve Stimulator, K090922)
Intended Use	Same intended use: symptomatic relief and management of chronic intractable pain.	Intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.	Intended for symptomatic relief and management of chronic intractable pain (and additionally for arthritis and post-surgical/post-trauma acute pain).
Basic Technological Characteristics	Similar characteristics (one stimulation channel, single output mode, patient controlled intensity, LED indicators, rechargeable battery). Differences should not raise new questions of safety or effectiveness.	One stimulation channelSingle output modePatient controlled intensityLED indicators (no intensity display)Powered by 1 rechargeable 3.7V Lithium-Ion batteryMethod of Line Current Isolation: Physically isolated; device cannot connect to electrodes and battery recharger concurrentlyNormal Condition Patient Leakage Current: < 10 µA, battery poweredSingle Fault Condition Patient Leakage Current: < 100 µA, battery poweredAverage DC current through electrodes (on, no pulse): < 1 μΑRegulated Current or Regulated Voltage: CurrentSoftware/Firmware/Microprocessor Control: YesAutomatic Overload Trip? YesAutomatic No-Load Trip? YesAutomatic Shut Off? Yes after timer elapsesUser Override Control? Yes, press STIM buttonOn/Off Status Indicator: Yes, upon pressing STIM buttonLow Battery Indicator: YesVoltage/Current Level Indicator: NoTimer Range: 60 minutesCompliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304:2006Compliance with 21 CFR 898: YesWeight: 95g (3.4 oz)Dimensions: 22mm (0.9") x 66mm (2.6") x 108mm (4.3")Housing Materials & Construction: Plastic	One stimulation channelSingle output modePatient controlled intensityLED indicators (no intensity display)Powered by 1 rechargeable battery (type unknown)Method of Line Current Isolation: Physically isolated; device cannot connect to electrodes and battery recharger concurrentlyNormal Condition Patient Leakage Current: UnknownSingle Fault Condition Patient Leakage Current: UnknownAverage DC current through electrodes (on, no pulse): UnknownRegulated Current or Regulated Voltage: Nominally constant voltage in the positive phase, nominally constant current in the negative phaseSoftware/Firmware/Microprocessor Control: YesAutomatic Overload Trip? NoAutomatic No-Load Trip? NoAutomatic Shut Off? Yes if left at 0 mA for 5 minutesUser Override Control? Yes, press POWER buttonOn/Off Status Indicator: Yes, status LED flashes when onLow Battery Indicator: YesVoltage/Current Level Indicator: NoTimer Range: N/ACompliance with Voluntary Standards: IEC 60601-1-2, UL: 60601-01, CAN/CSA C22.2 No.601.1-M90 with Amendment A2.2005Compliance with 21 CFR 898: YesWeight: 0.99 ozDimensions: 0.57"x1.94"x2.54"Housing Materials & Construction: Plastic
Output Specifications	Output parameters are within the range of legally-marketed TENS. Differences should not raise new questions of safety or effectiveness. Specific comparison focuses on pulse waveform, duration, max output voltage/current, and pulse pattern, arguing that these differences are minor and do not affect safety/effectiveness.	Waveform: BiphasicShape (output current): RectangularMaximum Output Voltage (10 +/- %): 50 V @500 Ω, 100 V @2000 Ω, 100 V @10000 ΩMaximum Output Current (10 +/- %): 100 mA @500 Ω, 50 mA @2000 Ω, 10 mA @10000 ΩDuration of primary (depolarizing) phase: 100 μsPulse Duration (both phases): 230 μs, includes 30 μs inter-phase delayFrequency: Constant, 80 HzMultiphasic, Symmetrical phases: YesNet Charge (per pulse): Nominally 0 μC @ 500Ω, zero net currentMaximum Phase Charge: 10 μC @ 500Ω, 10 μC @ 1000ΩMaximum Current Density (r.m.s.): 0.63 mA/cm² @ 500ΩMaximum Average Current: 1.6 mA @ 500 ΩMaximum Average Power Density: 4 mW/cm² @ 500ΩBurst Mode: N/A (all)ON/OFF Time: N/A (all)Additional Features: N/A	Waveform: BiphasicShape (output current): Approximately rectangular initial phase, slowly decaying second phaseMaximum Output Voltage (10 +/- %): 25 V @500 Ω, 35 V @2000 Ω, 39 V @10000 ΩMaximum Output Current (10 +/- %): 50 mA @500 Ω, 18 mA @2000 Ω, 4 mA @10000 ΩDuration of primary (depolarizing) phase: 400 μs at maximum intensityPulse Duration (both phases): Approximately 1 msec, exact duration unspecified due to slowly decaying second phaseFrequency: Modulated, 2-125 HzMultiphasic, Symmetrical phases: NoNet Charge (per pulse): Nominally 0 μC because pulse shape is described as balancedMaximum Phase Charge: 17 μC @ 500Ω, 10 μC @ 1000ΩMaximum Current Density (r.m.s.): 1.73 mA/cm² @ 500ΩMaximum Average Current: 10 mA @ 500ΩMaximum Average Power Density: 8 mW/cm² @ 500ΩBurst Mode: N/A (all) if not specifiedON/OFF Time: N/A (all) if not specifiedAdditional Features: N/A
Safety	Demonstrated conformity to relevant voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304) and 21 CFR 898.	Yes, conforms to listed standards. Electrical, mechanical, and software verification testing.	Yes, conforms to listed standards.
Effectiveness	Demonstrated through substantial equivalence to predicate device for the intended use and technological characteristics, particularly that differences in output do not raise new questions of effectiveness.	Non-clinical (bench) testing was sufficient to demonstrate safety and effectiveness.	Established through existing market history and 510(k) clearance.

2. Sample Size Used for the Test Set and Data Provenance

The provided document indicates that no clinical testing was performed to demonstrate the safety and effectiveness of the NeuroMetrix SENSUS. NeuroMetrix determined that non-clinical (bench) testing was sufficient. Therefore, there is no "test set" in the context of patient data, nor any data provenance information from patient studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As there was no clinical testing involving patient data, there was no ground truth established by experts for a test set. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and intended use against those of the legally marketed predicate device and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The NeuroMetrix SENSUS is a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI-powered diagnostic or interpretive device that would involve human readers or AI assistance in interpretation.

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

This question is not applicable to the NeuroMetrix SENSUS. It is a physical medical device that delivers electrical stimulation, not a software algorithm that performs diagnostic or interpretive functions. Its performance is evaluated based on its electrical output characteristics and functionality, not an "algorithm-only" performance in a diagnostic sense.

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

The "ground truth" for the submission is primarily the technical specifications and established safety/effectiveness of the predicate device (EMPI Active Transcutaneous Nerve Stimulator, K090922), combined with adherence to international voluntary standards (IEC 60601 series, IEC 62304) and FDA regulations (21 CFR 898). Essentially, the "ground truth" is that devices with similar specifications and intended use have been deemed safe and effective by regulatory bodies.

8. The sample size for the training set

Not applicable. As a TENS device, the NeuroMetrix SENSUS did not involve machine learning or AI models requiring a "training set" of data.

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

Not applicable, as no training set was used.

Summary

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5. 510(K) SUMMARY

510(k) Summary for NeuroMetrix SENSUS™

K121184

SPONSOR

NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451 USA

Contact Person:	Rainer Maas
Telephone:	(781) 314-2781
Date Prepared:	July 23, 2012

DEVICE NAME

Proprietary Name: SENSUS Common/Usual Name: Transcutaneous Electrical Nerve Stimulator, TENS Classification Name: 882.5890 GZJ Transcutaneous electrical nerve stimulator for pain relief

PREDICATE DEVICE

EMPI Active Transcutaneous Nerve Stimulator (K090922)

INTENDED USE

The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

DEVICE DESCRIPTION

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K12//84

The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector.

The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.

COMPARISON TO PREDICATE

The NeuroMetrix SENSUS device and predicate Empi Active Transcutaneous Nerve Stimulator (ACTIVE) have the same intended use, i.e., they are intended for the symptomatic relief and management of chronic intractable pain. The SENSUS Indications for Use represent a subset of the predicate Indications for Use. Specifically, while both SENSUS and the predicate are indicated for the relief and management of chronic intractable pain, the predicate is additionally indicated for the relief of pain associated with arthritis and as an adjunctive treatment for post-surgical and post-trauma acute pain. Both are prescription devices to be used under the direction of a medical professional.

SENSUS and the predicate have the same basic technological characteristics as listed below.

. One stimulation channel
Single output mode .
Patient controlled intensity .
LED indicators (no intensity display) .
Powered by rechargeable battery .

SENSUS and the predicate device have output characteristics that are within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators. The basic unit characteristics and output specifications of the two devices are summarized in the tables below.

Parameter	NeuroMetrix SENSUS	Empi Active TranscutaneousNerve Stimulator (K090922)
510(k) Number	(to be assigned)	K090922
Device Name and Model Number	SENSUS	Active Transcutaneous NerveStimulator
Manufacturer	NeuroMetrix	Empi
Power Source(s)	1 rechargeable 3.7V Lithium-Ion battery	1 rechargeable battery (typeunknown)
Method of Line Current Isolation	Physically isolated; devicecannot connect to electrodesand battery rechargerconcurrently	Physically isolated; device cannotconnect to electrodes and batteryrecharger concurrently
Patient Leakage Current
Normal Condition	< 10 µA, battery powered	Unknown
Single Fault Condition	< 100 µA, battery powered	Unknown
Average DC current throughelectrodes when device is on but no	< 1 μΑ	Unknown

Basic Unit Characteristics.

NeuroMetrix, Inc. SENSUS 510(k)

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・

pulse are being applied (µA)
Number of Output Modes		1	1
Numberof outputchannels	Synchronous oralternating	1	1
Method of channelisolation		N/A	N/A
Regulated Current or RegulatedVoltage		Current	Nominally constant voltage in thepositive phase, nominally constantcurrent in the negative phase
Software/Firmware/MicroprocessorControl		Yes	Yes
Automatic Overload Trip?		Yes	No
Automatic No-Load Trip?		Yes	No
Automatic Shut Off?		Yes after timer elapses	Yes if left at 0 mA for 5 minutes
User Override Control?		Yes, press STIM button	Yes, press POWER button
IndicatorDisplay:	On/Off Status?	Yes, upon pressing STIMbutton	Yes, status LED flashes when on
	Low Battery?	Yes	Yes
	Voltage/CurrentLevel?	No	No
Timer Range		60 minutes	N/A
Compliance with VoluntaryStandards		IEC 60601-1IEC 60601-1-2	IEC 60601-1-2UL: 60601-01CAN/CSA C22.2 No.601.1-M90with Amendment A2.2005
Compliance with 21 CFR 898		Yes	Yes
Weight		95g (3.4 oz)	0.99 oz
Dimensions (W x H x D)		22mm (0.9") x 66mm (2.6")x108mm (4.3")	0.57"x1.94"x2.54"
Housing Materials & Construction		Plastic	Plastic

Output Specifications.

Parameter	NeuroMetrix SENSUS	Empi Active TranscutaneousNerve Stimulator (K090922)
Mode or Program Name	N/A	N/A
Waveform	Biphasic	Biphasic
Shape (output current)	Rectangular	Approximately rectangularinitial phase, slowly decayingsecond phase
Maximum Output Voltage (10 +/- %)	50 V @500 Ω100 V @2000 Ω100 V @10000 Ω	25 V @500 Ω35 V @2000 Ω39 V @10000 Ω
Maximum Output Current (10 +/- %)	100 mA @500 Ω50 mA @2000 Ω10 mA @10000 Ω	50 mA @500 Ω18 mA @2000 Ω4 mA @10000 Ω
Duration of primary (depolarizing) phase	100 μs	400 μs at maximum intensity
Pulse Duration (both phases)	230 μs, includes 30 μs inter-phase delay	Approximately 1 msec, exactduration unspecified due toslowly decaying second phase
Frequency	Constant, 80 Hz	Modulated, 2-125 Hz
For multiphasic	Symmetrical phases Yes	No

NeuroMetrix, Inc.
SENSUS 510(k)

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K12//84

waveforms only:	Phase Duration
Net Charge (per pulse)		Nominally 0 μC @ 500Ω, zero net current	Nominally 0 μC because pulse shape is described as balanced
Maximum Phase Charge		10 μC @ 500Ω10 μC @ 1000Ω	17 μC @ 500Ω10 μC @ 1000Ω
Maximum Current Density (r.m.s.)		0.63 mA/cm² @ 500Ω	1.73 mA/cm² @ 500Ω
Maximum Average Current		1.6 mA @ 500 Ω	10 mA @ 500Ω
Maximum Average Power Density		4 mW/cm² @ 500Ω	8 mW/cm² @ 500Ω
Burst Mode	Pulses per burst	N/A	N/A
	Bursts per second	N/A	N/A
	Burst duration	N/A	N/A
	Duty Cycle	N/A	N/A
ON Time		N/A	N/A
OFF Time		N/A	N/A
Additional Features		N/A	N/A
	100 μs (each phase)		400 μs (initial phase), at maximum intensity

The primary differences between the two devices relate to the output specifications, specifically the (i) pulse waveform shape and duration, (ii) maximum output voltage and maximum output current, and (iii) pulse pattern.

(i) Pulse waveform shape and duration: SENSUS generates a symmetrical biphasic rectangular output current pulse while ACTIVE generates a balanced asymmetrical biphasic pulse with the initial phase approximately rectangular and a slowly decaying second phase. The SENSUS pulse duration is fixed at 100 usec per phase while the initial phase of the ACTIVE pulse duration varies with the intensity setting, and the overall duration is approximately 1000 usec. Because the physiological effectiveness of nerve stimulation is primarily dependent on charge delivered, either pulse waveform shape will be effective. Therefore this difference does not raise new types of questions of safety or effectiveness. -
(ii) Maximum output voltage and maximum output current: SENSUS has a higher maximum output voltage than ACTIVE (50 V for SENSUS versus 25V for ACTIVE into a 500Ω load). SENSUS also has a higher maximum output current, i.e, 100 mA as compared to 50 mA in ACTIVE (500Ω Because the SENSUS pulse duration is shorter and the charge delivered per pulse is load). titrated by the patient, the maximum charge per pulse is similar for the two devices. Therefore this difference does not raise new types of questions of safety or effectiveness.
(iii)Pulse pattern: SENSUS stimulates with a fixed duration pulse at a constant frequency of 80 Hz while ACTIVE stimulates with pulses that automatically cycle through a range of durations and frequencies between 2 and 125 Hz. This difference between SENSUS and ACTIVE does not raise new types of safety or effectiveness questions because (i) neither device gives the patient control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (ii) constant frequency stimulation is standard practice, and (iv) the clinical effectiveness of transcutaneous electrical nerve stimulation for chronic intractable pain is not dependent on the use of modulated pulse trains such as those generated by ACTIVE, and can be achieved through either constant or modulated frequency and duration.

SENSUS and the predicate device have similar types of control over stimulation intensity, with minor differences in the specific user interaction sequences. These differences do not raise new types of safety or effectiveness questions because in both devices the (i) stimulation intensity is under patient control such that he/she can change the intensity, stop further intensity increases, and halt stimulation

NeuroMetrix, Inc. SENSUS 510(K)

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K12//84

at any time and (ii) the stimulation intensity always starts at 0 mA and increases gradually, smoothly and predictably, thereby avoiding the risk of sudden changes in intensity that may startle the patient.

In sum, SENSUS and the predicate have the same intended use and the only technological differences relate to several output specifications and aspects of intensity control. As discussed above, these differences in technological characteristics are relatively minor and do not raise new types of safety or effectiveness questions and do not adversely affect the safety and effectiveness of the SENSUS device compared to the predicate. As a result, the SENSUS device is substantially equivalent to the predicate ACTIVE device.

GUIDANCE DOCUMENT

The FDA's "Draft Guidance for Industry and Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (April 5, 2010)" addresses transcutaneous electrical nerve stimulators with product code GZJ. The recommendations from the draft guidance were taken into account in preparing this 510(k) submission. NeuroMetrix believes that SENSUS complies with the special controls as outlined in the draft guidance, thereby providing additional assurance of safe and effective use of the SENSUS device.

NON-CLINICAL TESTING

Verification testing of SENSUS includes electrical, mechanical, and software tests to show that the device meets its target specifications over a range of operating and storage conditions. Validation and performance testing demonstrates that it meets user needs as reflected in the functional specification.

SENSUS conforms to the following voluntary standards:

. IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 (300 Ed) plus Amendments 1:2006 and 2:2007
. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2007)
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements for Safety -. Collateral standard: Usability (3td Ed) 2010-1
IEC 62304:2006 Medical device software -- Software life cycle processes ●

CLINICAL TESTING

NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient to demonstrate that SENSUS is as safe and effective as the predicate.

CONCLUSION

The verification, validation and performance data presented in this 510(k) submission demonstrate that the NeuroMetrix SENSUS device is substantially equivalent to the predicate device.

NeuroMetrix, Inc. SENSUS 510(K)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle.

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

2 2012 AUG

NeuroMetrix, Inc. c/o Mr. Rainer Maas Director of QA/RA 62 Fourth Ave. Waltham, MA 02451

Re: K121184

Trade/Device Name: SENSUS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: July 23, 2012 Received: July 24, 2012

Dear Mr. Maas:

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

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Page 2 - Mr. Rainer Maas

device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Device Name: NeuroMetrix SENSUS

Indications for Use:

The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121184

Page 1 of 1

NeuroMetrix, Inc. SENSUS 510(k) Page 12

CONFIDENTIAL

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).