CUR Model 1

K160052 · Thimble Bioelectronics, Inc. · NUH · May 20, 2016 · Neurology

Device Facts

• Record ID: K160052
• Device Name: CUR Model 1
• Applicant: Thimble Bioelectronics, Inc.
• Product Code: NUH · Neurology
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles. The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.

Device Story

Wearable TENS/PMS device for pain relief and muscle performance. Input: user-selected intensity via device buttons or mobile app. Operation: device generates electrical pulses delivered through disposable polyacrylate hydrogel pads attached to skin. Output: electrical stimulation to nerves/muscles. Used in home/clinic settings by patients. Mobile app provides treatment controls, usage instructions, and warnings via Bluetooth. Device features magnetic attachment to gel pads and charging base. Benefits: portable, rechargeable, professional-grade therapy, convenient interface.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench and non-clinical testing, including electrical, mechanical, software verification, usability, and biocompatibility testing.

Technological Characteristics

Wearable TENS/PMS stimulator; 3.7V rechargeable Li-Polymer battery; polycarbonate housing; magnetic electrode attachment. Output: regulated current, 1 channel. Connectivity: Bluetooth for mobile app control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, ISO 10993-5/10, IEC 62304, IEC 62366-1. Software: microprocessor-controlled with automatic overload/no-load trip and shut-off.

Indications for Use

Indicated for adult patients for symptomatic relief/management of chronic intractable pain and temporary relief of pain in shoulder, waist, back, neck, arms, and legs due to exercise or household strain. Also indicated for powered muscle stimulation to improve/facilitate muscle performance in healthy muscles. Contraindicated for use on throat, chest, or head.

Regulatory Classification

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.

Predicate Devices

• NeuroMetrix ASCEND (K104333)
• Philips Consumer Lifestyle PulseRelief (K151035)

Submission Summary (Full Text)

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

May 20, 2016

Thimble Bioelectronics, Inc. Shaun Rahimi CEO 2011 26th St. Ste. 202 San Francisco. CA 94107

Re: K160052

Trade/Device Name: Cur Model 1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 15. 2016 Received: April 20, 2016

Dear Shaun Rahimi:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Michael J.Hoffmann -A

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

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### Indications for Use

510(k) Number (if known) K160052

Device Name CUR Model 1

#### Indications for Use (Describe)

A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and

A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.

The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.

| Type of Use (Select one or both, as applicable) | | |
|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------|
| <table><tr><td>☐ Research Use (Part 21 CFR 821 Subpart B)</td><td>☑ Study That Controls (21 CFR 821 Subpart C)</td></tr></table> | ☐ Research Use (Part 21 CFR 821 Subpart B) | ☑ Study That Controls (21 CFR 821 Subpart C) |
| ☐ Research Use (Part 21 CFR 821 Subpart B) | ☑ Study That Controls (21 CFR 821 Subpart C) | |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized flower-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company name.

# 510(k) Summary for CUR Model 1

This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92

| Submitter Information: | |
|------------------------|---------------------------------------------------|
| Sponsor Name | Thimble Bioelectronics, Inc. |
| Contact Person | Shaun Rahimi, CEO |
| Address | 2011 26th St. Ste. 202<br>San Francisco, CA 94107 |
| Telephone | [phone] |
| Fax | ----- |
| Email | [e-mail] |
| Submission Date | January 09, 2016 |

### Submitter Information:

#### Device Information:

| Device Name | CUR Model 1 |
|---------------------|-----------------------------------------------------------|
| Common Name | Transcutaneous Nerve Stimulator |
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Classification | Class II<br>21 CFR 882.5890; 21 CFR 890.5850<br>Neurology |

### Predicate Devices

The CUR device is substantially equivalent to the NeuroMetrix ASCEND (K104333) and the Philips Consumer Lifestyle PulseRelief (K151035) devices.

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Image /page/4/Picture/0 description: The image contains the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company name.

### Device Description

CUR is a high-quality wearable medical device that provides professional-grade TENS therapy along with an easy-to-use interface and compact aesthetic design. It is comprised of the main CUR device, a disposable gel pad, and a charging cable with AC adapter for recharging the device.

A use session typically begins with the user placing the Gel Pad on the skin near the location of pain, attaching the CUR Device to the Gel Pad using the magnetic attachment points on the bottom surface of the Device and on the plastic connector of the Gel Pad. The user then presses the power "start/stop" button on the Device to begin treatment. The user may use buttons on the Device labeled with standard ISO "+" and "-" symbols to control the intensity of treatment. They also may connect the Device to a compatible Mobile Device via Bluetooth and control treatment through the CUR Mobile App. After treatment is finished, the user may leave the Device attached to the Gel Pad until the next treatment session, or may remove the Device from the Gel Pad and attach the Device to the Charging Base using the magnetic attachment points on the Device and Charging Base to store and re-charge the Device.

CUR Model 1 may be used for pain relief on most parts of the body. Intended placements include:

- Shoulder ●
- Waist ●
- Back
- Neck
- Upper extremities (arm) ●
- Lower extremities (leg)

Do not place CUR Model 1 on the throat, chest, or head.

The disposable Gel Pad utilizes a high-quality polyacrylate hydrogel material that provides excellent patient comfort, biocompatibility, and adherence to a wide range of skin types. Pads typically last about 6-10 days with regular daily use and storage before needing to be replaced. And since the Device uses an internal rechargeable battery for power, no other batteries or consumables are needed offering increased convenience and positive benefit to the environment.

The Mobile App provides access to treatment controls and usage instructions for the device from a compatible mobile device. This is an added convenience for cases where the user would rather adjust the treatment from their mobile devices rather than directly from the app and also a means of providing detailed warnings and usage instructions information in a portable way that the user can access at any time.

### Indications for Use

A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief

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Image /page/5/Picture/0 description: The image contains the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.

of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and

A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.

The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.

### Substantial Equivalence

The CUR Model 1 device indications for use and technological characteristics are substantially equivalent to the NeuroMetrix ASCEND device application (K104333) and Philips Consumer Lifestyle PulseRelief device application (K151035).

### Comparison Table – Indications for Use

#### Table 1: Indications for Use Comparison Table

| Parameter | Subject Device | Predicate | Predicate |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CUR Model 1 | NeuroMetrix<br>ASCEND<br>(K104333) | Philips Consumer<br>Lifestyle PulseRelief<br>(K151035) |
| Indication for<br>Use | A transcutaneous electrical nerve<br>stimulation (TENS) Mode which<br>is indicated for the symptomatic<br>relief and management of<br>chronic intractable pain, and for<br>temporary relief of pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, neck, upper extremities<br>(arm) and lower extremities (leg)<br>due to strain from exercise or<br>normal household work<br>activities. , and<br><br>A powered muscle stimulation<br>(PMS) mode which is indicated<br>to improve and facilitate muscle<br>performance in healthy muscles.<br><br>The CUR Model 1 should be<br>applied to normal, healthy, dry<br>and clean skin of adult patients. | ASCEND is intended for<br>use as a transcutaneous<br>electrical nerve stimulation<br>device for the symptomatic<br>relief and management of<br>chronic intractable pain.<br><br>ASCEND is intended for<br>use as a transcutaneous<br>electrical nerve stimulation<br>device for temporary relief<br>of pain associated with sore<br>and aching muscles in the<br>lower extremities due to<br>strain from exercise or<br>normal household and work<br>activities.<br><br>The device may be used<br>during sleep. The device is<br>labeled for use only with<br>compatible NeuroMetrix<br>electrodes. | The OTC TENS/EMS<br>stimulator PulseRelief is<br>designed to be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back,<br>neck, upper extremities<br>(arm) and lower<br>extremities (leg) due to<br>strain from exercise or<br>normal household work<br>activities. It should be<br>applied to normal,<br>healthy, dry and clean<br>skin of adult patients, and<br>is to be used for stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance. |
| Class | II | II | II |
| Product Code | NUH; NGX | NUH | NUH; NGX |
| Regulation | 21 CFR 882.5890(b) | 21 CFR 882.5890(b) | 21 CFR 882.5890(b) |

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Image /page/6/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.

| Number | CFR 890.5850 | 21 CFR 890.5850 |
|--------|--------------|-----------------|
|--------|--------------|-----------------|

## Comparison Tables – Technological Characteristics

### Basic Unit Characteristics

#### Table 2: Basic Unit Characteristics Comparison Table

| Parameter | | Thimble<br>CUR Model 1 | Neurometrix<br>Ascend | Philips<br>Pulserelief |
|----------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------|
| 510(k) Number | | (to be assigned) | K140333 | K151035 |
| Device Name and Model Number | | CUR Model 1 | Ascend | PulseRelief |
| Manufacturer | | Thimble Bioelectronics | NeuroMetrix | Philips<br>Consumer<br>Lifestyle |
| Power Source(s) | | 3.7V Lithium-Polymer<br>battery (rechargeable) | 3.7V Lithium-ion<br>battery<br>(rechargeable) | 3.7V Lithium-ion |
| Method of Line Current Isolation | | Physically isolated;<br>device cannot connect<br>to electrodes and<br>battery recharger<br>concurrently | Physically isolated;<br>device cannot<br>connect to<br>electrodes and<br>battery recharger<br>concurrently | N/A |
| Patient Leakage Current | | Battery powered | Battery powered | Battery powered |
| | - Normal Condition (μA) | (< 10 μA) | (< 10μA) | (< 10μA) |
| Patient Leakage Current | | Battery powered | Battery powered | Battery powered |
| | - Single Fault Condition (µA) | (< 50 μA) | (< 100μA) | (< 50μA) |
| Average DC current through electrodes<br>when device is on but no pulses are being<br>applied (μΑ) | | < 0.1μA | < 1μA | 0 μΑ |
| Number of Output Modes | | 3 TENS, 1 EMS | 1 | 15 TENS, 5 EMS |
| Number of Output<br>Channels: | Synchronous or<br>Alternating? | 1 | 1 | 1 |
| | Method of<br>Channel<br>Isolation | N/A | N/A | N/A |
| Regulated Current or Regulated Voltage? | | Current | Current | Current |
| Software/Firmware/Microprocessor<br>Control? | | Yes | Yes | Yes |
| Automatic Overload Trip? | | Yes | Yes | Yes |
| Automatic No-Load Trip? | | Yes | Yes | Yes |
| Automatic Shut Off? | | Yes | Yes | Yes |
| User Override Control? | | Yes | Yes | Yes |
| Indicator Display: | On/Off Status? | Yes | Yes | Yes |
| | Low Battery? | Yes | Yes | Yes (on app) |
| | Voltage/Current<br>Level? | Yes | No | Yes (on app) |

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Image /page/7/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, lighter font. The logo is simple and modern, with a focus on the company's name and field of expertise.

| Parameter | Thimble<br>CUR Model 1 | Neurometrix<br>Ascend | Philips<br>Pulserelief |
|--------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Compliance with Voluntary Standards? | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 10993-5 and -10 | IEC 60601-1<br>IEC 60601-1-2<br>EN 1497 60601-2-10<br>ISO 10993-5 and -10 | IEC 60601-1, IEC<br>60601-1-2, IEC<br>60601-2-10, ISO<br>10993-5 and -10 |
| Compliance with 21 CFR 898? | N/A | Yes | Yes |
| Weight (g) | 11.5 g | 82 g | 62 g |
| Dimensions (mm) (W x H x D) | 36 x 36 x 8.5 | 176 x 63 x 18 | 2 units, each 54 x 54 x<br>14 |
| Housing Materials and Construction | Polycarbonate plastic | Plastic, Velcro®<br>straps (Nylon) | PC/ABS plastic |

### Output Specifications Table for TENS Modes

Table 3: Output Specification for TENS Mode Comparison Table

| Parameter | CUR Model 1<br>Mode A<br>(Default Mode) | CUR Model 1<br>Mode B | CUR Model 1<br>Mode C | PulseRelief<br>(K151035) | NeuroMetrix ASCEND<br>(K140333) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------|--------------------------|---------------------------------------------------------|--------------------|
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic,<br>Asymmetrical | Biphasic,<br>Symmetrical | Biphasic,<br>Symmetrical | Biphasic,<br>Symmetrical | Biphasic, Symmetrical | |
| Shape (e.g., rectangular, spike) | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage (volts)<br>(+/-10%) | 42.6V @ 500Ω | 43.2V @ 500Ω | 42.9V @ 500Ω | 31 @500Ω | 50V @ 500Ω | |
| | 85.2V @ 2kΩ | 85.4V @ 2kΩ | 86.0V @ 2kΩ | 69 @ 2 kΩ | 100V @ 2kΩ | |
| | 87.0V @ 10kΩ | 85.4V @ 10kΩ | 87.8V @ 10kΩ | 70 @10 kΩ | 100V @ 10kΩ | |
| Maximum Output Current (mA)<br>(+/-10%) | 85.1 mA @<br>500Ω | 86.3 mA @<br>500Ω | 85.6 mA @<br>500Ω | 62 @500Ω | 100mA @ 500Ω | |
| | 43.1 mA @ 2kΩ | 43.2 mA @ 2kΩ | 43.5 mA @<br>2kΩ | 34 @ 2 kΩ | 50mA @ 2kΩ | |
| | 8.8 mA @ 10kΩ | 8.8 mA @ 10kΩ | 8.8 mA @<br>10kΩ | 7 @10 kΩ | 10mA @ 10kΩ | |
| Duration of primary (depolarizing) phase (usec) | 91.7 usec | 90.5 usec | 51.0 usec | 25 ~175 µs | 100 µs | |
| Pulse Duration (both phases) (usec) | 91.7 usec | 221 usec | 142 usec | 60 ~ 350 µs | 200µs, additional 30µs<br>inter-phase delay | |
| Frequency (Hz) | 40-130 Hz | 40-130 Hz | 120-160 Hz | 1 ~ 100 Hz | Random, mean 80Hz,<br>uniform distribution 60-<br>100Hz | |
| For<br>multiphasic<br>waveforms<br>only: | Symmetrical<br>phases? | | | | Yes | Yes |
| | Phase Duration<br>(include units),<br>(state range, if<br>applicable),<br>(both phases, if<br>asymmetrical) | No<br>91.7 usec<br>(primary phase)<br>0 usec @ 500Ω<br>(second phase) | Yes<br>90.5 usec | Yes<br>51.0 usec | 25 ~ 175 µs | 100µs (each phase) |

1 Duration of second phase is load dependent.

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| Parameter | CUR Model 1<br>Mode A<br>(Default Mode) | CUR Model 1<br>Mode B | CUR Model 1<br>Mode C | PulseRelief<br>(K151035) | NeuroMetrix ASCEND<br>(K140333) |
|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------|--------------------------|----------------------------------------|
| Net Charge (microcoulombs (µC) per pulse) (If zero, state how this was achieved) | 7.16µC @ 500Ω<br>(Nominally 0µC @500Ω per pair of consecutive pulses, zero net current) | Nominally 0µC @ 500Ω, zero net current | Nominally 0µC @ 500Ω, zero net current | 0µC @ 500Ω | Nominally 0µC @ 500Ω, zero net current |
| Maximum Phase Charge, (µC) | 7.16 µC @ 500Ω | 7.45 µC @ 500Ω | 4.14 µC @ 500Ω | 1.6 ~ 6.8 µC @ 500Ω | 10 µC @ 500Ω |
| Maximum Current Density, (mA/cm2, r.m.s.) | 0.35 mA/cm2 @500Ω | 0.50 mA/cm2 @500Ω | 0.42 mA/cm2 @500Ω | 0.002 ~ 0.045 @500Ω | 0.51 mA/cm2 @ 500Ω |
| Maximum Average Current (average absolute value), mA | 0.94 mA @500Ω | 1.85 mA @500Ω | 1.28 mA @500Ω | 0.06 ~1.36 @500Ω | 1.6 mA @ 500Ω |
| Maximum Average Power Density, (W/cm2), (using smallest conductive surface area) | 1.50 mW/cm2 @500Ω | 3.05 mW/cm2 @500Ω | 2.09 mW/cm2 @500Ω | 0.24 ~ 1.69 @500Ω | 3.6 mW/cm2 @ 500Ω |
| Burst Mode (i.e., pulse trains): | (a) Pulses per burst<br>N/A | N/A | N/A | 5, 7 | N/A |
| | (b) Bursts per second<br>N/A | N/A | N/A | 1,2,3 | N/A |
| | (c) Burst duration (seconds)<br>N/A | N/A | N/A | 62.5 ~ 87.5 | N/A |
| | (d) Duty Cycle:<br>Line (b) x Line (c)<br>N/A | N/A | N/A | 6.3%~ 19% | N/A |

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Image /page/9/Picture/0 description: The image shows the logo for Thimble Bioelectronics. The logo consists of a stylized leaf-like symbol on the left, followed by the word "Thimble" in a bold, sans-serif font. Below "Thimble" is the word "Bioelectronics" in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company's name and its connection to bioelectronics.

### Output Specifications Table for PMS Modes

Table 4: Output Specifications for EMS Mode Comparison Table

| Parameter | | CUR Model 1<br>(Preset Mode D) | PulseRelief<br>(K151035) |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------|
| Mode or Program Name | | Measured<br>(or Nominal as noted) | from 510k |
| Waveform (e.g., pulsed monophasic, biphasic) | | Biphasic, Symmetrical | Biphasic, Symmetrical |
| Shape (e.g., rectangular, spike) | | Rectangular | Rectangular |
| Maximum Output Voltage (volts) (+/-10%) | | 38.4V @ 500Ω | 31 @500Ω |
| | | 85.0V @ 2kΩ | 69 @ 2 kΩ |
| | | 85.0V @ 10kΩ | 70 @10 kΩ |
| Maximum Output Current (mA) (+/-10%) | | 76.7 mA @ 500Ω | 62 @500Ω |
| | | 43.0 mA @ 2kΩ | 34 @ 2 kΩ |
| | | 8.1 mA @ 10kΩ | 7 @10 kΩ |
| | Duration of primary (depolarizing) phase (usec) | 221.5 usec | 75 ~175 µs |
| Pulse Duration (both phases) (usec) | | 483.8 usec | 150 ~ 350 µs |
| | | | |
| Frequency (Hz) | | 2-15 Hz | 40 ~ 65 Hz |
| For<br>multiphasic | Symmetrical phases? | Yes | Yes |
| waveforms<br>only: | Phase Duration (include units), (state range, if<br>applicable), (both phases, if asymmetrical) | 221.5 usec | 75 ~ 175 µs |
| Net Charge (microcoulombs (µC) per pulse) (If zero, state how<br>this was achieved) | | Nominally 0uC @ 500Ω,<br>zero net current | 0uC @ 500Ω |
| Maximum Phase Charge, (μC) | | 16.21uC @ 500Ω | 4.7 ~10.9 uC @ 500Ω |
| Maximum Current Density, (mA/cm2, r.m.s.) | | 0.16<br>mA/cm2 @500Ω | 0.0019 ~ 0.037 @500Ω |
| Maximum Average Current (average absolute value), mA | | 0.22 mA @500Ω | 0.047 ~ 0.93 @ 500Ω |
| Maximum Average Power Density, (W/cm2), (using smallest<br>conductive surface area) | | 0.315 mW/cm2 @500Ω | 0.62~1.15 mW/cm2 @500Ω |
| Burst Mode<br>(i.e., pulse | (a) Pulses per burst | N/A | N/A |
| trains): | (b) Bursts per second | N/A | N/A |
| | (c) Burst duration (seconds) | N/A | N/A |
| | (d) Duty Cycle: Line (b) x Line (c) | N/A | N/A |

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### Non-Clinical Testing

Non-clinical verification testing of the CUR Model 1 device included electrical, mechanical, and software tests to show the device meets its design specifications. Validation and performance testing validates that the device meets its user needs. Verification and validation test results established that the device meets its intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The CUR device was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:

Safety:

- . IEC 60601 1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint)
- IEC 60601-2-10: 2012 (Second Edition) ●
- IEC 60601-1-11: 2010 (First Edition):

#### EMC:

- . IEC 60601-1-2:2014
- . FCC part 15 RADIO FREQUENCY DEVICES, Subpart B-Unintentional Radiators, Subpart C-Intentional Radiators.

#### Software:

- IEC 62304:2006 .
#### Usability

- . IEC 62366-1:2015
Biocompatibility:

- ISO 10993-5:2009 .
- . ISO 10993-10:2010

### Clinical Testing

Thimble determined that bench and non-clinical testing were sufficient to demonstrate that the CUR Model 1 device is as safe and effective as the predicate devices.

### Conclusion

The intended use and basic technological characteristics of the CUR Model 1 device are substantially equivalent with those of the references predicate devices. Any technological differences do not raise new questions regarding safety and effectiveness. The verification, validation, and performance data presented in this submission demonstrate that the CUR Model 1 device is substantially equivalent to the predicate Ascend and PulseRelief devices.