(175 days)
Not Found
No
The device description and performance studies focus on standard electrical stimulation and heating functions, with no mention of AI or ML algorithms for analysis, control, or personalization.
Yes
The device is described as an "Electronic Stimulator" with functions for "temporary relief of pain associated with sore and aching muscles" and "temporary relief of minor aches and pains" through electrical stimulation and heating, which clearly indicate a therapeutic purpose.
No
Explanation: The device is described as an "Electrical stimulator" and "TENS device" intended for "temporary relief of pain associated with sore and aching muscles" and "temporary relief of minor aches and pains" through electrical stimulation and heating functions. Its purpose is therapeutic (pain relief), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "portable and battery-powered TENS device" and details hardware components like a controller with built-in electrodes, a remote control, adapter, gel electrodes, and an external connection coupling. It also mentions electrical stimulation and heating functions, which are hardware-based. While there is software verification and validation, the device is fundamentally a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary relief of pain associated with sore and aching muscles" and "temporary relief of minor aches and pains" through electrical stimulation and heating. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a TENS device that applies electrical pulses and heat to the body. This is consistent with a physical therapy or pain relief device, not a device that analyzes samples from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
In summary, the device's function and intended use are focused on providing physical relief and therapy, not on diagnosing or monitoring a medical condition through in vitro analysis.
N/A
Intended Use / Indications for Use
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Note1 : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Product codes (comma separated list FDA assigned to the subject device)
NUH, IRT
Device Description
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, back of neck, arm, and leg
Indicated Patient Age Range
Not Found
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)
The following performance data (nonclinical testing) were provided in support of the substantial equivalence determination.
- Biocompatibility Safety
The materials of the patient-directly contacting components of the Electronic Stimulator is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
- EMC and Electrical Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
-
Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. -
Other Performance Verification
- The electrodes performance test has been conducted to verify the current dispersion and shelflife of the electrodes used by the device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
- The waveform and output test has also been conducted to verify the output specifications of the device according to the FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning.
Summary: Based on the above performance as documented in this application, the Electronic Stimulator was found to have a safety and effectiveness profile that is similar to the predicate device.
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2023
Shenzhen Leqing Medical Instrument Co., Ltd % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road Nanshan District Shenzhen, Guangdong 518000 China
Re: K223428
Trade/Device Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A. LO-9525B. uNeck-9512A. uNeck-9515A. uNeck-9517B. uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 12, 2023
Dear Rain Yip:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K223428
Device Name
Electronic Stimulator (Models: uLumb-9530A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Indications for Use (Describe)
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: May 8, 2023
I. Submitter
Shenzhen Leqing Medical Instrument Co.,LTD 2-3/F, Building D, No.31 Fangkeng Road, Longgang, Shenzhen, Guangdong, China Post code: 518000 Tel .: +86 755 2839 2373
Shaodong Wang Management Representative Tel: +86 135 9035 9865 Email: wangsd@pentasmart.com.cn
II. Device
Trade Name: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck- 9529A, LQ-9535A) Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: II Product Code: NUH. IRT Regulation Number: 21 CFR 882.5890
III. Predicate Device
Primary Predicate device: 510(k) number: K211942 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Heating Lumbar Therapy Cushion/AST-622 Product code: NGX, NUH, IRT Approval date: December 13, 2021
Secondary predicate device: 510(k) number: K190783 Manufacturer: Shenzhen OSTO Technology Company Limited Trade name: Health Expert Electronic Stimulator/AST-300L Product code: NUH, NGX Approval date: March 14, 2020
4
IV. Device Description
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
V. Indications for Use
Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Note1: The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Model): uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
VI. Comparison of Technological Characteristics With the Predicate Device
5
Compare with predicate devices, the Electronic Stimulator is very similar in the same technical characteristics, features, specifications, materials, mode of operation, intended use, and the applicable standards. The differences between subject device and the predicate devices do not raise new questions of safety or effectiveness.
6
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
|---|---|---|---|---|---|
| 510(k) number | Pending | K190783 | K211942 | ||
| Device name | Electronic Stimulator | Health Expert Electronic Stimulator | Heating Lumbar Therapy Cushion | ||
| Model(s) | uLumb-9530A, | ||||
| uLumb-9531A, | |||||
| uLumb-9532A, | |||||
| uLumb-9533A, LQ- | |||||
| 9525B | uNeck-9512A, | ||||
| uNeck-9515A, | |||||
| uNeck-9517B, | |||||
| uNeck-9518A, | |||||
| uNeck-9519A, | |||||
| uNeck-9521A, | |||||
| uNeck-9529A, LQ- | |||||
| 9535A | AST-300L | AST-622 | |||
| Manufacturer | Shenzhen Leqing Co.,LTD | Medical Instrument | Shenzhen OSTO Technology Company Limited | Shenzhen OSTO Technology Company Limited | |
| Indication for | |||||
| use/Intended use | Electrical simulation: | ||||
| To be used for | |||||
| temporary relief of | |||||
| pain associated with | |||||
| sore and aching | |||||
| muscles in the | |||||
| shoulder, waist, back, | |||||
| back of neck, arm, and | |||||
| leg, due to strain from | |||||
| exercise or normal | |||||
| household and work | |||||
| activities. | |||||
| Notel: The electrode | |||||
| on the stimulator is | |||||
| used in the waist. | |||||
| Note2: The additional | |||||
| gel patch is used in | |||||
| shoulder, waist, back, | |||||
| back of neck, arm | Electrical simulation: | ||||
| To be used | |||||
| for | |||||
| temporary relief of | |||||
| pain associated with | |||||
| sore and aching | |||||
| muscles in the back of | |||||
| neck, due to strain | |||||
| from exercise or | |||||
| normal household and | |||||
| work activities. | |||||
| Heating: To be used | |||||
| for temporary relief of | |||||
| minor aches and | |||||
| pains. | PMS (Mode 1~8) | ||||
| It is intended to stimulate healthy | |||||
| muscles in order to improve and | |||||
| facilitate muscle performance. | |||||
| TENS (Mode 9~25) | |||||
| To be used for temporary relief of pain | |||||
| associated with sore and aching | |||||
| muscles in the shoulder, waist, back, | |||||
| back of the neck, arm, leg, and foot due | |||||
| to strain from exercise or normal | |||||
| household work activities by applying | |||||
| current to stimulate nerve. | PMS(1 ~ 2): It is intended to stimulate | ||||
| healthy muscles in order to improve and | |||||
| facilitate muscle performance. | |||||
| TENS(3 ~ 5): To be used for temporary | |||||
| relief of pain associated with sore and | |||||
| aching muscles in the shoulder, waist, | |||||
| back, arm and leg due to strain from | |||||
| exercise or normal household work | |||||
| activities by applying current to | |||||
| stimulate nerve. | |||||
| Heating: The Heating Lumbar Therapy | |||||
| Cushion is intended for temporary relief | |||||
| of minor aches and pains. | |||||
| Comparison items | Subject device | Secondary Predicate devices | Primary predicate device | ||
| and leg. | |||||
| Heating: To be used | |||||
| for temporary relief of | |||||
| minor aches and | |||||
| pains. | |||||
| Location for use | OTC | OTC | OTC | ||
| Power source(s) | Powered by the | ||||
| internal rechargeable | |||||
| battery, 7.4Vd.c., | |||||
| 2600mAh | Powered by the | ||||
| internal rechargeable | |||||
| battery, 3.7Vd.c., | |||||
| 700mAh (uNeck- | |||||
| 9512A, uNeck- | |||||
| 9515A, uNeck- | |||||
| 9517B, uNeck- | |||||
| 9518A, uNeck- | |||||
| 9519A) |
Powered by the
internal rechargeable
battery, 3.7Vd.c.,
$280mAh*2$ (uNeck-
9521A)
Powered by the
internal rechargeable
battery, 3.7Vd.c.,
1200mAh (uNeck-
9529A, LQ-9535A) | Adaptor Input: 100-240Vac, 50-60Hz,
0.1A, Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | Power by adapter, 100-240VAC, 50-60Hz, Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | |
| Charged by the
external adapter: | Charged by the
external adapter: | | | | |
| Comparison items | Subject device | | Secondary Predicate devices | Primary predicate device | |
| | Input: 100-240Va.c.,
50/60Hz, 0.4A Max.
Output: 5.0Vd.c.,
2.0A | Input: 100-240Va.c.,
50/60Hz, 0.4A Max.
Output: 5.0Vd.c.,
1.0A | | | |
| -Method of Line
Current Isolation | Not applicable | | Type BF Applied Part | Type BF Applied Part | |
| -Patient
Leakage
Current | NC
(μA) | ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
2) EMC and Electrical Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
3) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
4) Other Performance Verification
-
The electrodes performance test has been conducted to verify the current dispersion and shelflife of the electrodes used by the device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
-
The waveform and output test has also been conducted to verify the output specifications of the device according to the FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning.
Summary
Based on the above performance as documented in this application, the Electronic Stimulator was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Clinical Testing Summary
Not applicable. Clinical testing was not performed to support this 510(k) submission.
17
IX. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Electronic Stimulator is to be concluded substantial equivalent to its predicate devices.