Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
Device Facts
| Record ID | K222870 |
|---|---|
| Device Name | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 |
| Applicant | Shenzhen Kentro Medical Electronics Co., Ltd. |
| Product Code | NUH · Neurology |
| Decision Date | May 10, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: · for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping · to temporarily increase local blood circulation in healthy leg muscles · to stimulate healthy muscles in order to improve and facilitate muscle performance · to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties · to relax muscle spasm · to increase blood flow circulation · for prevention of retardation of disuse atrophy · for muscle re-education · for maintaining or increasing range of motion · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis · Provide quadricep strengthening · Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: · symptomatic relief and management of chronic, intractable pain · relief of pain associated with arthritis · temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
Device Story
Device delivers electrical pulses to skin via electrode pads or footpads; provides TENS for pain relief and EMS for muscle stimulation. User operates device while seated or reclining; selects from 10 modes and 20 intensity levels via wireless remote control or main unit. LCD displays status. Power sources include AA batteries or rechargeable lithium batteries. Healthcare provider/patient uses output to manage pain, improve muscle performance, and increase circulation. Benefits include temporary pain relief, muscle strengthening, and adjunctive treatment for poor lower extremity blood flow.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety, electromagnetic compatibility, biocompatibility (ISO 10993), and software verification/validation.
Technological Characteristics
Materials: ABS housing, EVA foam/carbon film/hydrogel/PET electrode pads, silica gel or stainless steel footpads. Energy: 4.5V DC (AA batteries) or 3.7V DC (Li-ion). Waveform: Biphasic, pulsed symmetric, rectangular. Connectivity: Wireless remote control. Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-10, ISO 10993-5/10/23.
Indications for Use
Indicated for adult patients requiring symptomatic relief of chronic intractable pain, arthritis-related pain, or muscle pain due to strain. Also indicated for muscle conditioning, increasing local blood circulation, muscle re-education, maintaining range of motion, preventing disuse atrophy, relaxing muscle spasms, and post-surgical calf stimulation to prevent venous thrombosis.
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
- Transcutaneous Electrical Nerve Stimulator/ KTR-405 (K220998)
Reference Devices
- Electrode pads (K171381)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 10, 2023
Shenzhen Kentro Medical Electronics Co., Ltd % Yvonne Liu Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K222870
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, IPF, NYN, GZJ Dated: September 19, 2022 Received: September 22, 2022
Dear Yvonne Liu:
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.
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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 mediation-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.
# Pamela D. Scott -S
Pamela D. Scott 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
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## Indications for Use
510(k) Number (if known) K222870
#### Device Name
Transcutaneous Electrical Nerve Stimulator Model: KTR-4032. KTR-4012. KTR-4015. KTR-4015. KTR-4029. KTR-4027. KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039.
#### Indications for Use (Describe)
- 1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
- · for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities
- (arms) and lower extremities(legs) due to strain from exercise or normal household duties
- · to relax muscle spasm
- to increase blood flow circulation
- · for prevention of retardation of disuse atrophy
- for muscle re-education
- · for maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
- When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation 2)
- (TENS), it is intended to provide:
- · symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
- · temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
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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# 510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
## (1) Applicant information:
| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2nd Floor No 11, Shanzhuang Road, Xikeng Village, Yuanshan<br>Street, Longgang District, Shenzhen City, Guangdong Province,<br>China |
| Contact person: | Zewu Zhang |
| Phone number: | +86 755 3382 5998 |
| Fax number: | +86 755 3382 5996 |
| Email: | 522378976@qq.com |
| Date of summary prepared: | April 7, 2023 |
## (2) Reason for submission
New device, there were no prior submissions for the device.
# (3) Proprietary name of the device
| Trade name/model: | Transcutaneous Electrical Nerve Stimulator/ KTR-4031,<br>KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027,<br>KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037,<br>KTR-4039 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter;<br>Stimulator, Muscle, Powered, For Muscle Conditioning;<br>Stimulator, Muscle, Powered;<br>Stimulator, Electrical, Transcutaneous, For Arthritis;<br>Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation number: | 21 CFR 882.5890, 890.5850 |
| Product code: | NUH, NGX, IPF, NYN, GZJ |
| Review panel: | Neurology, Physical Medicine |
| Regulation class: | Class II |
#### (4) Predicate device
| | Predicate device |
|---------|------------------------------------------|
| Sponsor | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., |
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| | LTD |
|-----------------------|-----------------------------------------------------|
| Device Name and Model | Transcutaneous Electrical Nerve Stimulator/ KTR-405 |
| 510(k) Number | K220998 |
| Product Code | NGX, NUH, IPF, NYN, GZJ |
| Regulation Number | 21 CFR 890.5850, 882.5890 |
| Regulation Class | II |
#### (5) Description/ Design of device:
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy.
Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads. Models KTR-4031, KTR-4032, KTR-4012, KTR-4015 are powered by 3*AA batteries, models KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 are powered by 3.7V rechargeable lithium battery. The remote control is powered by 2*AAA batteries. To start therapy, you need to install 3*AA batteries to the main unit and 2*AAA batteries to the remote control or ensure the lithium battery power is sufficient. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
#### (6) Intended use / indications:
1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
· for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
· to temporarily increase local blood circulation in healthy leg muscles
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- · to stimulate healthy muscles in order to improve and facilitate muscle performance
· to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
- to relax muscle spasm
- to increase blood flow circulation
- · for prevention of retardation of disuse atrophy
- · for muscle re-education
- · for maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
· temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
| Component name | Material of Component | Body Contact Category | Contact Duration |
|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------|------------------|
| Body electrode pads | EVA foam, carbon film, hydrogel, PET | Surface skin contact | Permanent (>30d) |
| Foot pads (for models<br>KTR-4012, KTR-4015,<br>KTR-4021, KTR-4027,<br>KTR-4029, KTR-4031,<br>KTR-4032, KTR-4034,<br>KTR-4036, KTR-4039) | Silica gel | Surface skin contact | Permanent (>30d) |
| Foot pads (for models<br>KTR-4026 and<br>KTR-4037) | Stainless steel | Surface skin contact | Permanent (>30d) |
#### (7) Materials
We have directly purchased the electrode pads from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. Also we've conducted biocompatibility tests for foot pads and all pass. For details, please refer to "Biocompatibility Discussion".
#### (8) Technological characteristics and substantial equivalence
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| Item | Subject device | Predicate device | Remark |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade name | Transcutaneous Electrical Nerve<br>Stimulator<br>Model: KTR-4031, KTR-4032,<br>KTR-4012, KTR-4015, KTR-4029,<br>KTR-4027, KTR-4026, KTR-4021,<br>KTR-4034, KTR-4036, KTR-4037,<br>KTR-4039 | Transcutaneous Electrical Nerve<br>Stimulator<br>Model: KTR-405 | / |
| 510 (k) number | Pending | K220998 | / |
| Regulation<br>number | 21 CFR 882.5890, 890.5850 | 21 CFR 882.5890, 890.5850 | Same |
| Regulation<br>description | Transcutaneous electrical nerve<br>stimulator for pain relief; powered<br>muscle stimulator | Transcutaneous electrical nerve<br>stimulator for pain relief; powered<br>muscle stimulator | Same |
| Product code | NUH, NGX, IPF, NYN, GZJ | NUH, NGX, IPF, NYN, GZJ | Same |
| Class | II | II | Same |
| Indications for<br>use/ Intended<br>use | 1) When using Electrical Muscle<br>Stimulation, Transcutaneous<br>Electrical Nerve Stimulator is<br>intended:<br>● for users with conditions or<br>disease that are associated with<br>impaired (poor) blood flow in the<br>legs/ ankles/ feet, the device<br>through the foot-pads is intended<br>for use as an adjunctive treatment<br>(as an addition to your existing<br>treatment) to temporarily reduce<br>lower extremity pain, swelling and<br>cramping<br>● to temporarily increase local<br>blood circulation in healthy leg<br>muscles<br>● to stimulate healthy muscles<br>in order to improve and facilitate<br>muscle performance<br>● to temporarily relieve pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, upper extremities (arms) and<br>lower extremities (legs) due to<br>strain from exercise or normal<br>household duties | 2) When using Electrical Muscle<br>Stimulation, Transcutaneous<br>Electrical Nerve Stimulator is<br>intended:<br>● for users with conditions or<br>disease that are associated with<br>impaired (poor) blood flow in the<br>legs/ ankles/ feet, the device<br>through the foot-pads is intended<br>for use as an adjunctive treatment<br>(as an addition to your existing<br>treatment) to temporarily reduce<br>lower extremity pain, swelling<br>and cramping<br>● to temporarily increase local<br>blood circulation in healthy leg<br>muscles<br>● to stimulate healthy<br>muscles in order to improve and<br>facilitate muscle performance<br>● to temporarily relieve pain<br>associated with sore and aching<br>muscles in the shoulder, waist,<br>back, upper extremities (arms)<br>and lower extremities (legs) due<br>to strain from exercise or normal<br>household duties | Same |
| | to relax muscle spasm to increase blood flow circulation for prevention of retardation of disuse atrophy for muscle re-education for maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Provide quadricep strengthening Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: symptomatic relief and management of chronic, intractable pain relief of pain associated with arthritis temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties | to relax muscle spasm to increase blood flow circulation for prevention of retardation of disuse atrophy for muscle re-education for maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Provide quadricep strengthening Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: symptomatic relief and management of chronic, intractable pain relief of pain associated with arthritis temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties | |
| Patient<br>population | Adult | Adult | Same |
| OTC or<br>prescription | OTC | OTC | Same |
| <b>Basic unit specification</b> | | | |
| Power supply | KTR-4031, KTR-4032, KTR-4012,<br>KTR-4015 main unit: 4.5V DC 100mA or 3 AA batteries<br>KTR-4029, KTR-4027, KTR-4026,<br>KTR-4021, KTR-4034, KTR-4036 | Adaptor Input: 100-240AC,<br>50-60Hz, 0.2A<br>Output:5V, 1A<br>Unit Input: 5V, 1A | Different |
| | KTR-4037, KTR-4039 main unit:<br>Input: 5V DC 1A<br>Battery Capacity: 3.7V DC 2200mAh Lithium battery<br>Remote control: 2 AAA batteries | | |
| Leakage current | No earth leakage current | No earth leakage current | Same |
| Number of output modes | 10 | 10 | Same |
| Number of output channel | 2 | 2 | Same |
| Output intensity level | 20 | 150 | Different |
| -Synchronous or Alternating? | Synchronous | Synchronous | Same |
| Software/<br>Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Same |
| Automatic Overload trip | No | No | Same |
| Automatic no-load trip | No | No | Same |
| Patient override control method | On/Off button | On/Off button | Same |
| Indicator display | Yes | Yes | Same |
| -On/Off status | Yes | Yes | |
| -Low battery | Yes | Yes | |
| -Output mode | Yes | Yes | |
| -Time to cut-off | Yes | Yes | |
| Automatic Shut Off | Yes | Yes | Same |
| Dimensions | KTR-4012, KTR-4015, KTR-4032, KTR-4034, KTR-4036, KTR-4037, KTR-4039: 350×350×68.5mm<br>KTR-4021, KTR-4026, KTR-4027, KTR-4029, KTR-4031:<br>365×365×68.5mm | 330 (W) x 327 (H) x 92 (D) mm | Different |
| Weight | About 1670g | 1.5Kg (Without accessories) | Different |
| Housing<br>material and<br>construction | ABS | ABS | Same |
| Compliance with<br>voluntary<br>standards | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10,<br>IEC 60601-1-11,<br>ISO10993-5;<br>ISO10993-10 | IEC 60601-1,<br>IEC 606061-1-2,<br>IEC 60601-2-10,<br>IEC 60601-1-11,<br>ISO10993-5;<br>ISO10993-10 | Same |
| Compliance with<br>21CFR 882 and<br>890 | Yes | Yes…
