E-PULSE

• K Number: K091875
• Device Name: E-PULSE
• Manufacturer: MEDEVICE CORPORATION
• Date Cleared: 2009-12-07 ( 167 days)
• Product Code: BWK
• Regulation Number: N/A
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

E-pulse is an electro-acupuncture device for use in the practice of Acupuncture by qualified practitioners of acupuncture as determined by the state.

Device Description

Miniaturized, battery powered unit designed to administer auricular point stimulation treatment over a 96 hour period. The device is on for 3 hours, then off for 3 hours. It has a pre-programmed micro-processor as to frequency, pulse and duration for the stimulation of the auricular acupuncture points. The device itself is applied on the neck, below the ear with the integrated selfadhesive electrode patch. The voltage source is from the three batteries 1.4 volts (each). The device has different frequency modes and waveform modes. The wires from the device are connected to the acupuncture needles simply by positioning and snapping a plastic ring over the semi-permanent acupuncture needles.

AI/ML Overview

The provided document describes the E-pulse model UH900, an electro-acupuncture device, and its substantial equivalence to a predicate device (P-Stim). The study design focuses on testing the device's technical specifications and safety rather than clinical efficacy with human subjects.

Here's a breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Design Objective)	Reported Device Performance (Test Results)
Pulse Timing: Output pulse timing consistent with 1.1 ms +/- 10% wide positive and negative pulses, 1100ms +/- 10% impulse interval (1.1Hz).	PULSE TIMING: "Output pulse timing measurement of the unit under (UUT) test were taken with the oscilloscope and tabulated in output specifications." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results."
Pulse Level: Output pulse voltage level and waveform consistent with design objective (max. 4.2V, output amplitude diminishes with battery voltage).	PULSE LEVEL: "Load resistors as per table 2 have been attached to the output leads of the unit under (UUT) test, output pulse voltage readings taken with the oscilloscope." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results."
Pulse Cycle: Unit output pulse ON (3 hours) and OFF (3 hours) cycle, and end of life time interval (up to 96 hours).	PULSE CYCLE: "The unit operation was observed over the time period specified and output pulse ON and OFF cycle and end of life time interval results recorded in device wave forms." (Implies consistency with specified limits; no specific deviation reported, but "passes if within specified limits" is the design pass criterion.) The document also states: "Performance testing was performed and all tests show satisfactory results."
EMC (Immunity): Output pulse stability maintained independent of applied Rf-radiation according to IEC 60601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity.	EMC: "The methods applied were in accordance with IEC601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity." (Implies passing, as "Nonclinical testing... show satisfactory results" is stated.)
EMI (Emissions): Unit complies with paragraph 36.201 Amendment 1 IEC 60601-2-10 1987 Emissions and CISPR 11.	EMI: "The EMI test methods applied were in accordance with paragraph 36.201 Amendment 1 IEC 60601-2-10 1987 Emissions and CISPER 11." (Implies passing, as "Nonclinical testing... show satisfactory results" is stated.)
Watchdog Timer Functionality: Designed to shut down unit and return all outputs to zero if output pulse exceeds 2 ms; unit remains shut down.	Watchdog Timer: "A watchdog timer is employed to ensure proper code execution, It is designed to shut the unit down and return all outputs to zero if the output pulse exceeds 2 ms. The unit will remain in shut down mode as long as power is applied." (Described as incorporated functionality, implying it meets this criterion.)

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

The document describes non-clinical performance and safety testing directly on the device itself, not on biological samples or patient data.

• Sample Size: Not explicitly stated as a number of devices, but the phrasing "the unit under test (UUT)" suggests individual units were tested for each performance characteristic.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting, likely by the manufacturer or a contracted testing facility. The standards cited (IEC 60601 series, CISPR 11) are international standards for medical electrical equipment.

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

Not applicable. This was a technical performance and safety study conducted on the device hardware and software, not a study requiring expert clinical assessment for ground truth. The "ground truth" was the device's technical specifications and compliance with international standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments. This study involved objective measurements of electrical output and compliance with safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an electro-acupuncture device, and the study presented in the 510(k) summary is focused on technical performance and safety, establishing substantial equivalence to a predicate device. There is no mention of human readers, AI, or comparative effectiveness in a clinical context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device has software (firmware), the study described is not an "algorithm-only" performance study in the typical sense of AI/image analysis. It's a study of the device's overall hardware and embedded software functionality in meeting its design specifications. It evaluates the device's physical outputs (pulses, voltage, timing, cycles) and its electromagnetic compatibility/interference. There is no indication of a separate standalone performance evaluation of the "algorithm" in isolation from the hardware.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for this study was the pre-defined technical specifications and regulatory standards (e.g., pulse width 1.1ms +/- 10%, max. 4.2V output, 3-hour on/off cycle, compliance with IEC 60601 standards). These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning study where a training set (or a "test set" in the context of clinical performance evaluation) is used. The "training set" concept is irrelevant here as it's an engineering verification and validation study.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set in the context of this device's evaluation.

Summary

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K091875

510 (K) Summary

In accordance with requirements of 21 CFR 807.92(c)

June 19, 2009

The Assigned 510K number: 091875

• 1. Submitter Name: AMM Marketing LLC
• 2. Owner: AMM Marketing LLC EIN # 26-3986255

DEC - 7 2009

• 3. Preparer: Tzvi Milshtein
     S. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
• 4. Address: 4652 Coral Ridge Drive, Coral Springs Florida 33076
• 5. Tel: [phone] Fax [phone]
• 6. Contact Person: Tzvi Milshtein
• 7. Email: [e-mail]
• 8. Device name E-pulse model UH 900, common name: Electro Acupuncture Device. Classification code : BWK
• 9. The indication for use of the E-pulse is an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state.
• 10. The legally marketed device which E-pulse is claiming equivalence to is the P-Stim
• 11. Miniaturized, battery powered unit designed to administer auricular point stimulation treatment over a 96 hour period. The device is on for 3 hours, then off for 3 hours. It has a pre-programmed micro-processor as to frequency, pulse and duration for the stimulation of the auricular acupuncture points. The device itself is applied on the neck, below the ear with the integrated selfadhesive electrode patch.

The voltage source is from the three batteries 1.4 volts (each). The device has different frequency modes and waveform modes. The wires from the device are connected to the acupuncture needles simply by positioning and snapping a plastic ring over the semi-permanent acupuncture needles.

The software for each device is pre-configured during manufacturing and may not

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be accessed by either the user or the practitioner.

Safety features are incorporated into the device to reduce possibility of misuse.

The software used in this unit is considered firmware since it resides within an 80C51 type microprocessor hardware. It resides in 1 k byte-erasable Flash code memory organized into 256-byte sectors and 16-byte pages

The program language used is microprocessor adapted C-code. Internal timers are being employed to establish pulse width timing, pulse interval and pulse cycle. The code is optimized to reduce power consumption. There are no Interface Requirements. The code consists of a single loop. No operating system is involved. No Off-the Shelf software is used.

A watchdog timer is employed to ensure proper code execution, It is designed to shut the unit down and return all outputs to zero if the output pulse exceeds 2 ms. The unit will remain in shut down mode as long as power is applied.

Software capable was created to be generating a pulse stream output on two Output pins of the microprocessor.

The pulse stream is to consist of a repetitive 1.1 ms +/- 10% wide positive and one minute later a 1.1 ms +/- 10% wide negative pulse.

The pulse train is to continue for 3 hours after which it is to shut down for 3 hours. This cycle is to continue until the battery is run down or 96 hours have expired have been expired.

The watchdog timer is to be used to reset the outputs to zero and shut the unit down. The code is to be structured for minimum power consumption

Output: (Load impendence range 1kΩ to 10K) max. 4.2V, Impulse interval 1100ms +/- 10%,, Impulse width 1.1ms +/- 10%, (1.1Hz / 1.1ms / bipolar), max possible total duration of treatment 4 x 24 hours. The amplitude of the output signal diminishes in proportion to battery voltage

Protection level: IP 20 Type B

Duty type: approx. 3h duty / 3h at rest

Weight incl. battery: 4g | Dimensions: 23 x 8 mm

Needle Dimensions: 1.3 mm width x 3.1 mm length

• 12. Substantial equivalence is claimed based upon a comparison of the E-pulse To the P-stim, since both devices have the same intended use and similar operating principles . Both devices are electrical nerve stimulators with a single output channel and mode. Also, they have similar pulse width and frequencies. Both use a conductive gel product between the electrode and the patient's skin. Technical differences do not affect the safety or efficiency of the product.

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Predicate Product Comparison Table

Similarities

Similarities
Manufacturer	AMM Marketing LLC	NeuroScience Therapy CorpBiegler
Trade name	E-pulse	P-Stim
K #	91875	50123
Indication forUse	The indication for use of the E-pulse is an electroacupuncture device for use in the practice ofacupuncture by qualified practitioner of acupunctureas determined by the state	The indication for use of the E-pulse is anelectroacupuncture device for use in the practice ofacupuncture by qualified practitioner ofacupunctureas determined by the state
DeviceDescription	Battery powered unit designed to administerauricular point nerve stimulation treatmentfor pain therapyover a 96 hour period via electrical pulsingthe device is on for 3 hours then off for 3 hoursthe device is controled by a micro processor	A micro stimulation appliance for paintherapymicro processor controled,it generates a lowfrequency and continunal electrical pulsewhichis transmitted to the nerve endings of theearit allowes continues therapy over severaldays
TargetPopulation	Patients having acute or chronical pain	Patients having acute or chronical pain
HumanFactors	To be applied by a qualified practitionerof acupuncture	To be applied by an acupuncturer
Where Used	At the clinic and at home	At the clinic and at home
Performance	Monophasic pulses width at 1mS at 1Hz frequencyPerformance testing was performed and all testsshow satisfactory results	Monopahsic pulses at 1mS rectangular 1HzPerformance testing was performed andthey show satisfactoryresults
SoftwareBased	Yes	Yes
Duration	96 Hours	96Hours
Differences
Manufacturer	AMM Marketing LLC	NeuroScience Therapy CorpBiegler
Trade name	E-pulse	P-Stim
K #	91875	50123
SemiPermanentneedles	Titaniumhook shaft	Titaniumstraight shaft
ECG	shelf item by ConMed	Custom
Shape	Round23mm	Eliptic 42mm by 20mm

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Technological Characteristics of the E-pulse does not raise any new type of safety and effectiveness questions. The operating technology, the method of pulsing transmission via wires, the micro processing, electrical power source, wire termination transmission through similar acupuncture needles are all substantially equivalent.

• 13. The system-level test protocol consists of the measurements of the specified test
      parameters outlined in the Description above using an oscilloscope.

The design is considered to pass if the test results are within the specifieds limits.

Perfomance nonclinical data

Nonclinical testing: The device was tested in accordance with the tests specified in

IEC 60601-2-10:2000,60601-1-2:2007,60601-2-10:1987

and the EMC & EMI lab testing

• PULSE TIMING. Verify that the output pulse timing is consistent with the 1. design objective.
• 2. PULSE LEVEL. Verify that the output pulse voltage level and waveform is consistent with the design objective.
• PULSE CYCLE. Verify unit output pulse ON and OFF cycle and end of life time 3. interval.
• EMC. To ensure that the output pulse stability is maintained independent of the 4. applied Rf-radiation according to IEC601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity.
• EMI. EMI test to ensure that the unit complies with paragraph 36.201 ร์ Amendment 1 IEC 60601-2-10 1987 Emissions.
• PULSE TIMING. Output pulse timing measurement of the unit under (UUT) 1. test were taken with the oscilloscope and tabulated in output specifications
• PULSE LEVEL. Load resistors as per table 2 have been attached to the output 2. leads of the unit under (UUT) test, output pulse voltage readings taken with the oscilloscope.
• 3. PULSE CYCLE. The unit operation was observed over the time period specified and output pulse ON and OFF cycle and end of life time interval results recorded in device wave forms.
• 4. EMC. The methods applied were in accordance with IEC601-2-10 paragraph 36, Test 1 and paragraph 36.202 Amendment 1 IEC 60601-2-10 1987 Immunity. EMI. The EMI test methods applied were in accordance with paragraph 36.201

Amendment 1 IEC 60601-2-10 1987 Emissions and CISPER 11.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is black and white.

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

AMM Marketing LLC c/o Tzvi Milshtein Manager 4652 Coral Ridge Drive Coral Springs, FL 33076

Re: K091875

DEC - 7 2009

Trade/Device Name: E-PULSE, model UH900 Regulation Number: n/a Regulation Name: n/a Regulatory Class: Class II Product Code: BWK Dated: October 20, 2009 Received: October 23, 2009

Dear Mr. Milshtein:

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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Tzvi Milshtein

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 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kira Alexander for

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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Indications for Use

510(k) Number (if known): K091875

Device Name: E-pulse, Model UH900

Indications For Use:

E-pulse is an electro-acupuncture device for use in the practice of Acupuncture by qualified practitioners of acupuncture as determined by the state.

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)

Alesh

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K091876
510(k) Number

Regulation Number and Section

N/A