(130 days)
Not Found
No
The document describes a standard TENS/PMS device with manual intensity control and a mobile app for convenience. There is no mention of AI, ML, or any adaptive or learning algorithms. The performance studies focus on electrical, mechanical, and software safety and effectiveness against predicate devices, not on AI/ML performance metrics.
Yes.
The device is a transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (PMS) device indicated for symptomatic pain relief and muscle performance improvement, which are therapeutic uses.
No
Explanation: The device is described as a "transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain" and a "powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles." There is no mention of the device being used to diagnose conditions.
No
The device description explicitly states it is comprised of a "main CUR device, a disposable gel pad, and a charging cable with AC adapter," which are all hardware components. While it includes a mobile app for control, the core therapeutic function is delivered by the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CUR Model 1 is a transcutaneous electrical nerve stimulation (TENS) and powered muscle stimulation (PMS) device. It applies electrical impulses to the skin for pain relief and muscle performance improvement.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. It directly interacts with the body's tissues through electrical stimulation.
- Intended Use: The intended use is for symptomatic relief of pain and improvement of muscle performance, not for diagnosing or monitoring a condition based on laboratory analysis.
Therefore, the CUR Model 1 falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Waist, Back, Neck, Upper extremities (arm), Lower extremities (leg)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Over-The-Counter Use
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)
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
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.
NeuroMetrix ASCEND (K104333), Philips Consumer Lifestyle PulseRelief (K151035)
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely 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
2
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) | ||
|---|---|---|
| ☐ 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) |
| ☐ 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 |
| San Francisco, CA 94107 | |
| Telephone | (408) 799-8783 |
| Fax | ----- |
| shaun@cur.me | |
| 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 |
| 21 CFR 882.5890; 21 CFR 890.5850 | |
| 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 | ||
| ASCEND | |||
| (K104333) | Philips Consumer | ||
| Lifestyle PulseRelief | |||
| (K151035) | |||
| Indication 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 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. | ASCEND is intended for
use as a transcutaneous
electrical nerve stimulation
device for the symptomatic
relief and management of
chronic intractable pain.
ASCEND is intended for
use as a transcutaneous
electrical nerve stimulation
device for temporary relief
of pain associated with sore
and aching muscles in the
lower extremities due to
strain from exercise or
normal household and work
activities.
The device may be used
during sleep. The device is
labeled for use only with
compatible NeuroMetrix
electrodes. | The OTC TENS/EMS
stimulator PulseRelief is
designed to be used 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. It should be
applied to normal,
healthy, dry and clean
skin of adult patients, and
is to be used for stimulate
healthy muscles in order
to improve and facilitate
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
CUR Model 1 | Neurometrix
Ascend | Philips
Pulserelief |
|----------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------|
| 510(k) Number | | (to be assigned) | K140333 | K151035 |
| Device Name and Model Number | | CUR Model 1 | Ascend | PulseRelief |
| Manufacturer | | Thimble Bioelectronics | NeuroMetrix | Philips
Consumer
Lifestyle |
| Power Source(s) | | 3.7V Lithium-Polymer
battery (rechargeable) | 3.7V Lithium-ion
battery
(rechargeable) | 3.7V Lithium-ion |
| Method of Line Current Isolation | | Physically isolated;
device cannot connect
to electrodes and
battery recharger
concurrently | Physically isolated;
device cannot
connect to
electrodes and
battery recharger
concurrently | N/A |
| Patient Leakage Current | | Battery powered | Battery powered | Battery powered |
| | - Normal Condition (μA) | (