(94 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest any AI/ML functionality.
Yes
The device is described as a combined TENS and NMS device intended for various medical conditions like pain relief, muscle spasm relaxation, and prevention of disuse atrophy, which are therapeutic applications. Additionally, it has predicate devices (K041520 Mantra TENS Model NT3 and K021905 Classic NMS™) which are therapeutic devices.
No
Explanation: The device is intended for pain relief, muscle stimulation, and relaxation, not for diagnosing conditions. It is a therapeutic device.
No
The device description explicitly states it is "housed in small lightweight cabinet and is battery powered," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a TENS (Transcutaneous Electrical Nerve Stimulator) and NMS (Neuromuscular Stimulator) for pain relief, muscle stimulation, and related physical therapy applications. These are external, non-invasive treatments applied to the body.
- Device Description: The description confirms it's a battery-powered device for delivering electrical stimulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain diagnostic information. This device operates by applying electrical stimulation to the body.
N/A
Intended Use / Indications for Use
a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pair.
b. NMS: The device in recommended for use for the following conditions:
- Relaxation of muscle spasms
- Prevention of retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining and increasing range of motion.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.
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
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)
Performance testing was conducted on the "Mantra Combo" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the 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
091236
Page. 1/2
SECTION 5.0
Mantra International (HK) Ltd 1504 Vigor Industrial Building, Block B, 20 Cheung Tat Road Tsing Yi Hong Kong Tel: +852 2432 7181
JUL 3 0 2009
510(k) Summary
- General Information
Trade Name of Device:
"Mantra Combo"
Common/Usual Name:
Classification Name:
Submitters Name and Address:
Manufacturer:
Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator
Stimulator, Nerve, Transcutaneous for Pain Relief, Combined with Powered Muscle Stimulator
Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China
Mantra International (HK) Ltd. 1504 Vigor Industrial bldg Block B, 14-20 Cheung Tat Road Tsing Yi, Hong Kong, China Registration Number: 3003741750
Device Description
The "Mantra Combo" combined TENS and NMS dual channel device is housed in small lightweight cabinet and is battery powered. The same circuitry is used to for both TENS and NMS.
Indications for Use
a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post traumatic acute pair.
b. NMS: The device in recommended for use for the following conditions:
-
Relaxation of muscle spasms
-
Prevention of retardation of disuse atrophy
-
Increasing local blood circulation
-
Muscle re-education
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
Maintaining and increasing range of motion.
1
Lo91236. Page 2/2
Substantial Equivalence
This product is substantialiy equivalent to the Mantra TENS Model NT3 (K041520) Combined with the Classic NMS™ manufactured by Care Rehab Inc of McLean Virginia (K021905). The device is physically identical to both the Manta TENS NT3 and Classic NMS™ consisting of exactly the same cabinet, PCB and circuity. The TENS functionality (Modes and programs) of the Mantra COMBO is identicy.
the Mantra NT3 TENS and the NMS function in the Mantra COMBO is identical the Mantra NT3 TENS and the NMS functionality (modes and programs) is identical
the Mantra NT3 TENS and the NMS finctionality (modes and programs) is identical that of the Classic NMS™. Since the Classic NMS™ is also produced by Mantra International Ltd, all the technical characteristics, (including lead wires) are identical. The user can select either TENS or NMS modalities. In this way it is simply "two products in one".
Performance Studies
Performance testing was conducted on the "Mantra Combo" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device
6. Conclusion
ડી.
Based upon the Indications for use and performance studies the "Mantra Combo" has been shown to be substantially equivalent for its intended use.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2009
Mantra International, Ltd. c/o Mr. Brent Reider President, International Trade Group, Inc. 4663 Kate Lane Oxford. OH 45056
Re: K091236
Trade/Device Name: Mantra Combo Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: July 2, 2009 Received: July 7, 2009
Dear Mr. Reider:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Joe Callaway for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Mantra Combo (Combined TENS & NMS device)
Indications For Use:
a. TENS: The device is intended for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute nain surgical and post traumatic acutes an a
b. NMS: The device is recommended for use for the following conditions:
-
Relaxation of muscle spasms
-
Relaxation of muscle spasms
-
Prevention of retardation of disuse atrophy
-
Increasing local blood circulation
-
Muscle re-education
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
-
Maintaining and increasing range of motion
-
Maintaining and increasing range of motion.
iption Use _ AND/OR Over-The-Counter Use R 801 Subpart D)
(21 CFR 807 Subpart C)
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
07/20/09
ivision Sten of vision of Ophthalmic, Neurological and Ear, and Throat Devi
510(k) Number K091236
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