(428 days)
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No
The provided text describes a device using TENS, EMS, and NMES technologies for pain relief and muscle stimulation. There is no mention of AI, ML, or related concepts in the intended use, device description, or any other section.
Yes
The device is intended for the temporary relief and management of various types of pain, muscle stimulation, relaxation of muscle spasms, and improvement of blood circulation, which are all therapeutic claims.
No
The device's intended uses (pain relief, muscle stimulation, blood circulation improvement, etc.) are therapeutic and not diagnostic. It does not mention identifying or characterizing a disease or condition.
No
The intended use describes a device that applies "transcutaneous electrical current to stimulate the nerves" and "stimulate healthy muscles." This requires hardware components to deliver the electrical stimulation, making it a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Pain Therapy Device Function: The description clearly states that this device uses electrical stimulation (TENS, EMS, NMES) applied to the body (transcutaneous) to treat pain and muscle conditions. It does not involve analyzing samples taken from the body.
The intended uses and device description are consistent with a physical therapy or pain management device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pain Therapy Device (Model: P.T.S-X):
TENS (Transcutaneous electrical nerve stimulation):
-
For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
-
For relief of pain associated with arthritis.
-
For symptomatic relief and management of chronic intractable pain
EMS (Electrical muscle stimulation): -
To stimulate healthy muscles in order to improve and facilitate muscle performance.
-
To temporarily increase local blood circulation in healthy muscles.
NMES (Neuromuscular electrical stimulation):
-
For relaxation of muscle spasm.
-
Increase of blood flow circulation.
-
Prevention or retardation of disuse muscle atrophy.
-
Muscle re-education.
-
Maintaining or increasing range of motion.
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
-
For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Product codes
NGX, NUH, IPF, NYN, GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet), calf muscles, legs/ankle/feet.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 16, 2024
Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong China
Re: K230711
Trade/Device Name: Pain Therapy Device (Model: P.T.S-X) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, IPF, NYN, GZJ Dated: November 21, 2023 Received: November 21, 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
Your device is also subject to, among other requirements, the Quality System (QS) 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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
2
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) K230711
Device Name Pain Therapy Device (Model: P.T.S-X)
Indications for Use (Describe)
The Pain Therapy Device (Model: P.T.S-X):
TENS (Transcutaneous electrical nerve stimulation):
-
For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.
-
For relief of pain associated with arthritis.
-
For symptomatic relief and management of chronic intractable pain
EMS (Electrical muscle stimulation): -
To stimulate healthy muscles in order to improve and facilitate muscle performance.
-
To temporarily increase local blood circulation in healthy muscles.
NMES (Neuromuscular electrical stimulation):
-
For relaxation of muscle spasm.
-
Increase of blood flow circulation.
-
Prevention or retardation of disuse muscle atrophy.
-
Muscle re-education.
-
Maintaining or increasing range of motion.
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
-
For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NEMS through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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