(333 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is of a standard electro-acupuncture stimulator with basic controls. There is no mention of any features or functionalities that would suggest the use of AI or ML.
Yes
The device is described as an "electro-acupuncture stimulator device" indicated for use in "acupuncture therapy," which implies a therapeutic purpose.
No
The device is described as an "electro-acupuncture stimulator device" used for "acupuncture therapy," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is composed of a console, electrode cables, and is powered by batteries or AC, indicating it is a hardware device with electrical components, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Needle Stimulator is an electro-acupuncture device that applies electrical stimulation to the body through needles. It does not involve the analysis of biological samples.
The provided information clearly describes a device used for therapeutic purposes in the practice of acupuncture, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
BWK
Device Description
Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture
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)
Needle Stimulator is safe and effective as the predicate devices cited above. The new devices have passed testings according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD);
- IEC 60601-1-2: Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests;
- IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
The conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed 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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services - USA. To the right of the seal is the FDA logo in blue, with the letters "FDA" in a bold, sans-serif font. Underneath the letters "FDA" is the text "U.S. FOOD & DRUG ADMINISTRATION" in a smaller, sans-serif font, also in blue. The logo is simple and professional, and it is easily recognizable.
August 27, 2021
Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Regulatory Assurance No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China
Re: K202861
Trade/Device Name: Needle Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: August 9, 2021 Received: August 13, 2021
Dear Caihong Sun:
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.
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
1
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).
Sincerely,
Jitendra V. Virani -S
For
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202861
Device Name Needle Stimulator
Indications for Use (Describe)
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information: 510(k) Number: K202861 Date: April 1st, 2021 Type of 510(k) Submission: Traditional Modified device Basis for 510(k) Submission: Submitter/Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116 Contact: Doris Dong [Consultant, from Shanghai CV Technology Co., Ltd.] Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China E-mail: doris.d(@ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-57712250
2. Device Description:
| Proprietary Name: | Needle Stimulator |
|---|---|
| Model: | CMNS6-1, CMNS6-2 |
| Common Name: | Electro-Acupuncture |
| Product Code: | BWK |
| Device Class: | Unclassified |
| Review Panel: Device | Neurology |
| Description: | Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles. |
| Indications for use: | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. |
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 10.1 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 1-
| Parameters | Modified Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| 1 | 510(k) Number: | K202861 | K130768 | -- | |
| 2 | Marketing clearance | ||||
| date: | No | August 16, 2013 | -- | ||
| 3 | Device Name | Needle Stimulator | Jiajian® CMN Stimulator | -- | |
| 4 | Model | CMNS6-1 | / | -- | |
| 5 | Manufacturer | Wuxi Jiajian Medical Instrument Co.,Ltd | Wuxi Jiajian Medical Instrument Co.,Ltd | Same | |
| 6 | Intended use | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Jiajian® CMN Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Same | |
| 7 | Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 | Same | ||
| Note 1 | |||||
| Method of Line Current Isolation | Type BF | Type BF | Same | ||
| 8 | Patient Leakage |
Current | -- | -- | Same | |
| | Normal Condition (μΑ) | 2μΑ | 2μΑ | | |
| | Single Fault
Condition (μΑ) | ≤50μΑ | ≤50μΑ | | |
| 9 | Average DC current through electrodes when device is on but no pulses are being applied (μΑ) | N/A | N/A | Same | |
| 10 | Number of Output Modes | 3 (continuous wave/ interrupted wave/ Dense-disperse wave) | 3 (continuous wave/ interrupted wave/ Dense-disperse wave) | Same | |
| | Number of Output channels: | 6 (3 channels at most work together on single patient) | 6 (3 channels at most work together on single patient) | Same | |
| 11 | - Synchronous or Alternating? | Synchronous | Synchronous | Same | |
| | Method of Channel Isolation | Transformer | Transformer | Same | |
| 12 | Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Same | |
| 13 | Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |
| 14 | Automatic Overload Trip? | No | No | Same | |
| 15 | Automatic No-Load Trip? | No | No | Same | |
| 16 | Automatic Shut Off? | Yes | Yes | Same | |
| 17 | User Override | Yes | Yes | Same | |
| | Control? | | | | |
| 18 | | On/Off
Status? | Yes | Yes | Same |
| | | Low
Battery? | Yes | Yes | Same |
| | Indicator
Display: | Voltage/Current
Level? | Yes | Yes | Same |
| | 19 | Timer
(minutes) | Range | 0-60min | 0-60min |
| 20 | Compliance with
Voluntary Standards? | | IEC 60601-1, IEC 60601-2-10,
IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10,
IEC 60601-1-2 | Same |
| 21 | Compliance with 21
CFR 898? | | Yes | Yes | Same |
| 22 | Weight (grams) | | 740g | 740g | Same |
| 23 | Dimensions [W x H x D] | | 23015555mm | 23015555mm | Same |
| 24 | Housing Materials &
Construction | | ABS; Injection molded | ABS; Injection molded | Same |
| 25 | Waveform | | Biphasic | Biphasic | Same |
| 26 | Shape | | Asymmetric biphasic square
wave | Asymmetric biphasic square
wave | Same |
| 27 | Maximum Output
Voltage (volts) | | 27V±10% @500Ω | 27V±10% @500Ω | Same |
| | | | 60.4V±10% @2kΩ | 60.4V±10% @2kΩ | Same |
| | | | 75V±10% @10kΩ | 75V±10% @10kΩ | Same |
| 28 | Maximum Output
Current (specify units) | | 54mA±10% @500Ω | 54mA±10% @500Ω | Same |
| | | | 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same |
| | | | 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same |
| 29 | Pulse
width
(µsec) | Positive | 200µs±10% | 200µs±10% | Same |
| | | Negative | 1030µs (5.15 x (+Phase) ) | 1030µs (5.15 x (+Phase) ) | Same |
| 30 | Pulse | Period (msec) | 101000ms | 101000ms | Same |
| 31 | Max. pulse frequency
(Hz) [or Rate (pps)] | | 1100Hz±10% | 1100Hz±10% | Same |
| 32 | Net Charge (µC per
pulse) | | 0µC@500Ω, + and – pulses
cancel | 0µC@500Ω, + and – pulses
cancel | Same |
| 33 | Maximum
Charge, (µC) | Phase | 9.4µC @500Ω | 9.4µC @500Ω | Same |
| 34 | Maximum Average
Current, (mA) | | 1.08mA @500Ω | 1.08mA @500Ω | Same |
| 35 | Maximum Current
Density, (mA/cm², r.m.s.) | | 9.4mA/cm² @500Ω | 13.3mA/cm² @500Ω | Same
Note 2 |
| | 36 | Maximum Average | | 0.141W/cm²@500Ω | 0.2W/cm²@500Ω |
| | Power
(W/cm²) | Density, | | | |
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | |
| 38 | Accessories | Lead wires, Alligator type connectors | Lead wires, Alligator type connectors | Same | |
4
5
6
Note 1:
Compared with the predicate device, the proposed device can be connected to AC power. Both of the AC power and DC power of the proposed device have passed IEC 60601-1 and EMC tests, and the description of AC power supply has been added to user manual. Therefore, this difference doesn't raise any safety and effectiveness issues.
Note 2:
The maximum current density and maximum power density are different between the proposed device and the predicate device because they are calculated by different needle surface areas. After calculation, both of them are within the safety limit. Therefore, this difference doesn't raise any safety and effectiveness issues.
Detailed comparison data is included in "Section 10.2 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 2-
| Parameters | Modified Device | Predicate Device | Remark | |||
|---|---|---|---|---|---|---|
| 1 | 510(k) Number: | K202861 | K130768 | -- | ||
| 2 | Marketing clearance date: | No | August 16, 2013 | -- | ||
| 3 | Device Name | Needle Stimulator | Jiajian® CMN Stimulator | -- | ||
| 4 | Model | CMNS6-2 | / | -- | ||
| 5 | Manufacturer | Wuxi Jiajian Medical Instrument Co.,Ltd | Wuxi Jiajian Medical Instrument Co.,Ltd | Same | ||
| 6 | Intended use | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Jiajian® CMN Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Same | ||
| 7 | Type of use | Prescription use | Prescription use | Same | ||
| Power Source(s) | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 | Same | |||
| Note 1 | ||||||
| - Method of Line Current Isolation | Type BF | Type BF | Same | |||
| 8 | - Patient Leakage Current | -- | -- | Same | ||
| -- Normal Condition (μΑ) | 2μΑ | 2μΑ | ||||
| -- Single Fault Condition (μΑ) | ≤50μΑ | ≤50μΑ | ||||
| 9 | Average DC current | N/A | N/A | Same | ||
| through | electrodes | |||||
| when device is on but | ||||||
| no pulses are being | ||||||
| applied (µA) | ||||||
| 10 | Number of Output Modes | 3 (continuous wave/ | ||||
| interrupted wave/ | ||||||
| Dense-disperse wave) | 3 (continuous wave/ | |||||
| interrupted wave/ | ||||||
| Dense-disperse wave) | Same | |||||
| 11 | Number of Output channels: | 6 (3 channels at most work | ||||
| together on single patient) | 6 (3 channels at most work | |||||
| together on single patient) | Same | |||||
| - Synchronous or Alternating? | Synchronous | Synchronous | Same | |||
| - Method of Channel Isolation | Transformer | Transformer | Same | |||
| 12 | Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Same | ||
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |||
| 13 | ||||||
| 14 | Automatic Overload Trip? | No | No | Same | ||
| 15 | Automatic No-Load Trip? | No | No | Same | ||
| 16 | Automatic Shut Off? | Yes | Yes | Same | ||
| 17 | User Override Control? | Yes | Yes | Same | ||
| 18 | Indicator Display: | |||||
| On/Off Status? | Yes | Yes | Same | |||
| Low Battery? | Yes | Yes | Same | |||
| Voltage/Current Level? | Yes | Yes | Same | |||
| 19 | Timer (minutes) Range | 1-99min | 0-60min | Same | ||
| Note 2 | ||||||
| 20 | Compliance with Voluntary Standards? | IEC 60601-1, IEC 60601-2-10, | ||||
| IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10, | |||||
| IEC 60601-1-2 | Same | |||||
| 21 | Compliance with 21 CFR 898? | Yes | Yes | Same | ||
| 22 | Weight (grams) | approx. 657g | 740g | Same | ||
| 23 | Dimensions [W x H x D] | 23818475mm | 23015555mm | Same | ||
| Note 2 | ||||||
| 24 | Housing Materials & Construction | ABS; Injection molded | ABS; Injection molded | Same | ||
| 25 | Waveform | Biphasic | Biphasic | Same | ||
| 26 | Shape | Asymmetric biphasic square | Asymmetric biphasic square | Same | ||
| wave | wave | |||||
| 27 | Maximum | |||||
| Output | ||||||
| Voltage (volts) | 27V±10% @500Ω | 27V±10% @500Ω | Same | |||
| 60.4V±10% @2kΩ | 60.4V±10% @2kΩ | Same | ||||
| 75V±10% @10kΩ | 75V±10% @10kΩ | Same | ||||
| 28 | Maximum | Output | 54mA±10% @500Ω | 54mA±10% @500Ω | Same | |
| Current | (specify | 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same | ||
| units) | 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same | |||
| 29 | Pulse | Positive | 175µs±10% | 200µs±10% | Same | |
| width | ||||||
| (µsec) | Negative | 1051µs (6 x (+Phase) ) | 1030µs (5.15 x (+Phase) ) | Note 3 | ||
| 30 | Pulse | |||||
| Period (msec) | 10~1000ms | 10~1000ms | Same | |||
| 31 | Max. pulse frequency | |||||
| (Hz) [or Rate (pps)] | 1~100Hz±10% | 1~100Hz±10% | Same | |||
| 32 | Net Charge (µC per | |||||
| pulse) | 0µC@500Ω, + and - pulses | |||||
| cancel | 0µC@500Ω, + and - pulses | |||||
| cancel | Same | |||||
| 33 | Maximum | |||||
| Phase | ||||||
| Charge, (µC) | 8.225μC @500Ω | 9.4μC @500Ω | Same | |||
| Note 4 | ||||||
| 34 | Maximum | |||||
| Average | ||||||
| Current, (mA) | 0.945mA @500Ω | 1.08mA @500Ω | ||||
| 35 | Maximum | |||||
| Density, | ||||||
| r.m.s.) | Current | |||||
| (mA/cm², | 8.225mA/cm² @500Ω | 13.3mA/cm² @500Ω | ||||
| 36 | Maximum | |||||
| Power | ||||||
| (W/cm²) | Average | |||||
| Density, | 0.1234W/cm²@500Ω | 0.2W/cm²@500Ω | ||||
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | ||
| 38 | Accessories | Lead | ||||
| wires, Alligator | ||||||
| type | ||||||
| connectors | Lead | |||||
| wires, Alligator | ||||||
| type | ||||||
| connectors | Same |
7
8
Note 1:
Compared with the predicate device, the proposed device can be connected to AC power. Both of the AC power and DC power of the proposed device have passed IEC 60601-1 and EMC tests, and the description of AC power supply has been added to user manual. Therefore, this difference doesn't raise any safety and effectiveness issues.
Note 2:
The weight, dimensions and appearance of the proposed device are a little different from the predicate device K130768, but these differences are insignificant in the terms of safety or effectiveness. Besides, there is a difference in treatment time range between the proposed device and predicate device. The treatment time can be adjusted by user as they want. So, the difference of treatment time range will not raise any safety or effectiveness issue.
Note 3:
There is a difference in the pulse width between the proposed device and predicate device. Based on the calculation of maximum current density, maximum power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and all parameters have passed IEC 60601-2-10 test codes. So, the difference doesn't raise any new safety and effectiveness issues.
9
Note 4:
The Maximum Phase Charge of the proposed device are similar to the predicate device, and both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.The maximum average current of the proposed device is smaller than that of the predicate device which means the better safety. The maximum current density and maximum power density are different between the proposed device and the predicate device because they are calculated by different needle surface areas. After calculation, both of them are within the safety limit. Therefore, this difference doesn't raise any safety and effectiveness issues.
4. Test summary:
Needle Stimulator is safe and effective as the predicate devices cited above. The new devices have passed testings according to the following standards:
-
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD);
-
IEC 60601-1-2: Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests;
-
IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
The conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate device.