(156 days)
No
The device description and performance studies focus on standard electrical stimulation technology with manual controls and pre-set programs, with no mention of AI or ML capabilities.
Yes
The document explicitly states that the device is intended for therapeutic uses, such as pain relief (TENS) and muscle stimulation for various medical conditions (PMS/NMES) under prescription use.
No
The device is described as providing temporary relief of pain, symptomatic relief, management of pain, stimulation to improve muscle performance, and temporary relaxation of muscle spasm. These are all therapeutic or palliative functions, not diagnostic ones. The "Intended Use / Indications for Use" section focuses on treatment and symptom management, not on identifying or determining the nature of a condition.
No
The device description explicitly states it is a "main unit" with physical operating elements (buttons, LED screen) and connectors for electrodes, which are also physical components. It is a hardware device that delivers electrical pulses, not solely software.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The ManaFlexx 2 is an electrical stimulator (TENS and PMS/NMES) that delivers electrical pulses to the user's body through electrodes. It is used for pain relief and muscle stimulation.
- Intended Use: The intended uses described are all related to applying electrical stimulation to the body for therapeutic or performance enhancement purposes. There is no mention of analyzing biological specimens.
Therefore, the ManaFlexx 2 falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For Over-The-Counter Use:
TENS:
ManaFlexx 2 (MF002-OTC) is 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 and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, NYN, GZJ, IPF
Device Description
The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there is a LED screen to display the selected mode, intensity level and charging status. The electrode is a long strip shape, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit. The device has two models that have the same appearance, identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, and leg, abdomen, legs, and buttocks, lower extremities, calf muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Performance Testing: Bench testing was conducted to evaluate the safety and performance.
- Performance Testing Summary:
- General requirements for basic safety and essential performance (ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]): The test sample is the final, finished product. Acceptance Criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Result: Pass.
- Electromagnetic disturbances (IEC 60601-1-2 Edition 4.1 2020-09): The test sample is the final, finished product. Acceptance Criteria: No degradation of performance was found during test. Result: Pass.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11 Edition 2.1 2020-07): The test sample is the final, finished product. Acceptance Criteria: The device operates normally, and can provide basic safety and essential performance. Result: Pass.
- Requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60101-2-10 Edition 2.1 2016-04): The test sample is the final, finished product. Acceptance Criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Result: Pass.
- Dispersion and Shelf Life Test: The test sample is the final, finished product. Test Method: Measuring the resistance between each point in order to know the evenly distribute of the current based on the ohm's Law. Acceptance Criteria: The impedance change before the new and aging electrode, used electrode should not exceed +- 20% of the initial average impedance. Result: Pass.
- Waveform & Output Test: The test sample is the final, finished product. Test Method: Use Electrical Load as load, connect to matched electrodes. Then use oscilloscope to test the output waveform (voltage, frequency) between two electrodes. Acceptance Criteria: According to "IEC 60601-2-10, Particular requirements for the safety of nerve and muscle stimulators", the limitation of output parameters with 500Ω resistance load should meet the following requirement: The output current limit r.m.s. with 500Ω resistance load is 80mA. For pulse durations of less than 0.1s, the pulse energy with 500Ω resistance load shall not exceed 300mJ per pulse. The output voltage shall not exceed a peak value of 500V, when measured under open-circuit condition. Otherwise, the following two Acceptance Criteria for the device according to FDA Guidance. Maximum Power Density
§ 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
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November 3, 2023
ManaMed, Inc % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510000 China
Re: K231569
Trade/Device Name: ManaFlexx 2 (model: MF002-RX. MF002-OTC) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, GZJ, IPF Dated: May 25, 2023 Received: May 31, 2023
Dear Cassie Lee:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Robert Kang -S
for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231569
Device Name ManaFlexx 2(Model: MF002-RX, MF002-OTC)
Indications for Use (Describe) For Over-The-Counter Use:
TENS:
ManaFlexx 2 (MF002-OTC) is 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 and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.
1. Submitter's Information
Name: ManaMed Inc Address: 5240 W. Charleston Blvd. Suite 150.Las Vegas, NV 89146.USA Postal code: 89146 Contact name: Trevor Theriot Title: President Tel: 949-632-0355 Fax: 940-287-3510 E-mail: ttheriot@manamed.net
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: November 1, 2023
3. Subject Device Information
Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle Stimulation (PMS) unit, blood circulation, and muscle performance Trade Name: ManaFlexx 2 Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter Model: MF002-RX, MF002-OTC Regulatory Class: II Product Code: NUH, NGX, NYN, GZJ, IPF Regulation Number: 21 CFR 882.5890
- Predicate Device Information Predicate Device1 (Primary):
6
510(K) Number: K191151 Company Name: JKH USA, LLC Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Trade Name: JKH Stimulator Plus Model: PL-029K5BL, PL-029K15, PL-029T Regulation Number: 21 CFR 882.5890\ Regulatory Class: II Product Code: NUH, NGX, NYN, GZJ, IPF, IRT
Reference Device:
510(K) Number: K200237 Company Name: Shenzhen Kentro Medical Electronics Co., Ltd Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, China Trade Name: Transcutaneous Electronic Nerve Stimulator Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2302, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494. Regulation Number: 21 CFR 890.5850 Regulatory Class: II Product Code: NUH
5. Device Description
The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there are two snap connectors on the rear of the device which are for connecting with electrode. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, and there is a LED screen to display the selected mode, intensity level and charging status.
The electrode is a long strip shape with a size of 21cm x 5.3cm, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit.
The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.
7
6. Intended Use / Indications for Use
For Over-The-Counter Use: TENS:
ManaFlexx 2 (MF002-OTC) is 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 and work activities.
ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
ManaFlexx 2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
ManaFlexx 2 (MF002-OTC)is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
ManaFlexx 2 (MF002-RX) is intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
ManaFlexx 2 (MF002-RX) is intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
7. Comparison to predicate device and conclusion
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
8
| Elements of Comparison | Subject Device | Primary Predicate Device | Reference Device | Remark | |
|---|---|---|---|---|---|
| Device Name and Model | ManaFlexx 2 (MF002-RX, MF002-OTC) | JKH Stimulator Plus (PL-029K5BL, PL-029K15, PL-029T) | Transcutaneous | ||
| Electronic Nerve | |||||
| Stimulator (Model: | |||||
| KTR-2401, KTR-2402, | |||||
| KTR-2411, KTR-2412, | |||||
| KTR-2301, KTR-2302, | |||||
| KTR-2341, KTR-2342, | |||||
| KTR-2491, KTR-2492, | |||||
| KTR-2493, KTR-2494) | -- | ||||
| 510(k) Number | K231569 | K191151 | K200237 | -- | |
| Product Code | NUH, NGX, NYN, GZJ, IPF | NUH, NGX, NYN, GZJ, IPF, IRT | NUH | Similar | |
| Note 1 | |||||
| Intended Use | For Over-The-Counter Use: | ||||
| TENS: | |||||
| ManaFlexx 2 (MF002-OTC) is 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 and work activities. | |||||
| ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. |
PMS/NMES:
ManaFlexx 2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
ManaFlexx 2 (MF002-OTC)is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. | Over-The-Counter Use:
TENS:
PL-029K5BL, PL-029K15, and PL-029T are 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 and work activities.
PL-029K5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K5BL and PL-029K15 may be used during sleep.
The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes.
PMS:
PL-029K5BL, PL-029K15, and PL-029T are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for | Transcutaneous
Electronic Nerve
Stimulator is indicated 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. | Similar
Note 1 | |
| | | | | | |
| | For Prescription Use:
TENS:
ManaFlexx 2 (MF002-RX) is
intended for the following
use:
- Symptomatic relief and
management of chronic,
intractable pain - Adjunctive treatment for
post-surgical and post-
trauma acute pain - Relief of pain associated
with arthritis
PMS/NMES:
ManaFlexx 2 (MF002-RX) is
intended for the following
use: - Temporary relaxation of
muscle spasm - Prevention or retardation
of disuse atrophy - Muscle re-education
- Maintaining or increasing
range of motion - Increase of local blood flow
in the treatment area - Prevention of post-surgical
venous thrombosis through
immediate stimulation of calf
muscles | use in any therapy or for the
treatment of any medical
conditions or diseases.
PL-029K5BL, PL-029K15,
and PL-029T are also
intended to temporarily
increase local blood
circulation in the healthy
muscles of lower
extremities.
Heating: The device of PL-
029T is intended for
temporary relief of minor
aches and pains.
Prescription Use:
TENS: PL-029K5BL, PL-
029K15, and PL-029T are
intended for the following
use: - Symptomatic relief
and management of
chronic, intractable pain -
Adjunctive treatment for
post-surgical and post-
trauma acute pain - Relief
of pain associated with
arthritis
PMS: PL-029K5BL, PL-
029K15, and PL-029T are
intended for the following
use: - Temporary relaxation
of muscle spasm -
Prevention or retardation of
disuse atrophy - Muscle re-education
- Maintaining or increasing
range of motion - Increase of local blood
flow in the treatment area - Prevention of post-surgical
venous thrombosis through
immediate stimulation of
calf muscles | | | |
| Prescription or OTC | OTC and Prescription | OTC and Prescription | OTC | Same | |
| Power Source(s) | Rechargeable battery | Rechargeable or non-
rechargeable battery | For KTR-23XX
series: CR2032;
3Vdc; 240mAh
For KTR-24XX
series: PL301526;
3.7Vdc, 250mAh | Same | |
| Method of line current
isolation | Battery supply | Battery supply | Not public available | Same | |
| Patient leakage current: |