(151 days)
Not Found
No
The summary describes a standard electrical stimulation device with various modes and adjustable parameters, but there is no mention of AI or ML capabilities in the intended use, device description, or other sections.
Yes.
The device's stated "Intended Use / Indications for Use" clearly outline its purpose for symptomatic pain relief, muscle spasm relaxation, increasing local blood circulation, muscle re-education, and prevention of disuse atrophy, all of which are therapeutic applications.
No
The device is described as a stimulating device for pain relief, muscle re-education, and other therapeutic uses, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a large LCD display, dual output isolated channels, a rechargeable lithium battery, and open circuit detectors, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described (pain relief, muscle re-education, relaxation of muscle spasm, etc.) are all related to treating or managing conditions within the body. IVDs, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a portable electrical stimulation device that applies electrical currents to the body. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD-related terms: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or functions associated with IVD devices (reagents, assays, sample handling, etc.).
Therefore, the Ultima NEO TENS system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:
- Relaxation of muscle spasm;
- Increasing local blood circulation and muscle re-education;
- Prevention or retardation of disuse atrophy;
- Prevention of venous thrombosis of the calf muscles immediately after surgery;
- Maintaining or increasing range of motion.
MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:
- Symptomatic relief of chronic intractable pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF, LIH
Device Description
A portable TENS/EMS/MIC/IF combo device for pain relief or muscle re-education.
Features:
- Innovative design
- Large LCD display
- Dual output isolated channels
- One rechargeable lithium battery
- Adjustable frequency, pulse width, and timing parameters
- 18 different modes
- Timer option
- Doctor lock/unlock facility
- Open circuit detectors
- Non-volatile
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)
Not Found
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
JUN - 5 2012
510(k) Summary
Date of Summary prepared: 31 December 2011
Submitter: Pain Management Technologies Address: 1340 Home Ave. Bldg. A Akron, OH 44310 Tel (330)-564-0820 : Fax (330) 564-0818 : E-Mail josh@paintechnology.com :
Contact person: Joshua Lefkovitz
Address of the manufacturing facility:
EasyMed Instruments Co., Ltd 5/F-6/F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, Guangdong, China Zip code: 528300
Submitted Device:
Generic name: Powered Muscle Stimulator (PMS) (or Electrical Muscle Stimulator (EMS)), Transcutaneous Electrical Nerve Stimulator (TENS), Microcurrent (MIC) TENS stimulator and Interferential Current Therapy Stimulator (IF)
Ultima NEO Trade name:
Common name: For the TENS/MIC system-TENS device For the EMS system-Powered Muscle Stimulators For the IF system-Interferential Stimulator
Classification name: For EMS system
Powered Muscle Stimulator for re-education of muscles - IPF; 21 CFR 890.5850
For TENS / MIC system
Stimulator, Nerve, Transcutaneous, for Pain Relief - GZJ; 21 CFR 882.5890.
For IF system Interferential current therapy - LIH
1
Device Classification: For EMS, TENS / MIC and IF systems - Class II
Predicate Devices: EasyMed EMS/TENS Model NMS-28 (K050921); MT9000 Combo TENS/EMS/IF/MIC (K093138)/(Trade name : InTENSity™ Select Combo) ; GM3 Series IF TENS Model GM3X2IF (K032719)
The class of the predicate Devices: Class II
Device Description: A portable TENS/EMS/MIC/IF combo device for pain relief or muscle re-education.
Features:
- Innovative design
- · Large LCD display
- · Dual output isolated channels
- · One rechargeable lithium battery
- · Adjustable frequency, pulse width, and timing parameters
- 18 different modes
- · Timer option
- · Doctor lock/unlock facility
- · Open circuit detectors
- Non-volatile
The intended use of the device:
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:
- . Relaxation of muscle spasm;
- Increasing local blood circulation and muscle re-education; .
- Prevention or retardation of disuse atrophy; .
- Prevention of venous thrombosis of the calf muscles immediately . after surgery;
- . Maintaining or increasing range of motion.
MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
2
IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:
- Symptomatic relief of chronic intractable pain. .
The intended use and indications for use of the new device are very similar to that of the predicate devices.
Technological Comparison:
-
- The new device Ultima NEO is a portable electrotherapy device which combines four systems : Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Microcurrent (MIC) and Interferential (IF), into one enclosure. These four systems work separately. When one system is working, the others do not work and thus do not affected each other. This feature has been fully guaranteed by the design.
-
- The marketed device EasyMed EMS/TENS Model NMS-28 (K050921) combines the systems of a TENS and an EMS (Electrical Muscle Stimulator or Powered Muscle Stimulator), into one package. It is a digital TENS/EMS combo unit which has been well exploited the digital technology, supplying the user preset programs and manual selectable programs with full ranges of parameters.
-
- The new device Ultima NEO also combines the systems of TENS and EMS into one package. It is also substantial equivalent to the marketed device EasyMed EMS/TENS Model NMS-28 (K050921), their features and performances in muscle controlling as well as pain relief therapy are almost the same substantially.
-
- The designed circuitry of TENS and EMS modes in the new device Ultima NEO is almost the same as the marketed device EasyMed EMS/TENS Model NMS-28 (K050921). For the TENS and EMS systems, they are of almost the same circuit diagrams and same working principle; The main difference between the two devices is that the new device Ultima NEO is also combined the Microcurrent (MIC) and Interferential (IF) systems into one package. But these systems are worked separately.
-
- The marketed device MT9000 Combo TENS/EMS/IF/MIC (K093138) is a combo device which includes the Microcurrent stimulation system. The Microcurrent stimulation can be generated by a very low and relatively long period current. The specification of
3
microcurrent system in MT9000 Combo TENS/EMS/IF/MIC K093138 is very similar to that of Ultima NEO MIC system.
-
- The new device Ultima NEO is designed and combined the Interferential (IF) and Microcurrent (MIC) systems based on the design of EasyMed EMS/TENS Model NMS-28 (K050921). The introduction of marketed device GM3 Series IF TENS Model GM3X2IF (K032719) and MT9000 Combo TENS/EMS/IF/MIC (K093138) are for the purpose of comparison of the feature of Microcurrent (MIC) and Interferential (IF).
-
- The new device Ultima NEO is of the same ranges of parameters as those of marketed devices.
-
- The software of the new device Ultima NEO can be divided into four parts: the first for TENS system, the second for EMS system, the third for MIC system, and the four one for IF system. First of all, the part of software for TENS system of the new device Ultima NEO is only a subset of that of the marketed device EasyMed EMS/TENS Model NMS-28 (K050921). Secondly, the considerations on safety, effectiveness and reliability in NMS-28 (K050921) are also introduced into the EMS system of the new device; While the part of software for EMS system of the new device Ultima NEO is almost the same as that of the marketed device EasyMed EMS/TENS Model NMS-28 (K050921), by applying almost the same control methods for muscle contraction-relaxation. In other word, the TENS and EMS systems of the new device Ultima NEO are almost the same as those of the marketed device NMS-28 (K050921). Thirdly, the part of software for Microcurrent (MIC) system of the new device Ultima NEO is very similar to that of the marketed device MT9000 Combo TENS/EMS/IF/MIC (K093138). For the last, the part of software for Interferential (IF) system of the new device Ultima NEO is very similar to that of the marketed device GM3 Series IF TENS Model GM3X2IF (K032719)
- Both the new device Ultima NEO and the marketed devices
4
NMS-28 (K050921)/ GM3 Series IF TENS Model GM3X2IF (K032719)/ MT9000 Combo TENS/EMS/IF/MIC (K093138) are passed the same tests of applicable recognized international consensus standards.
-
- The accessories of the new device Ultima NEO are similar to those of the marketed devices.
Labeling Comparison: The Labelling is substantially equivalent to that of the predicate devices.
- The accessories of the new device Ultima NEO are similar to those of the marketed devices.
Safety information:
Design to comply with relevant safety applicable recognized consensus standards; the output enerqy is well controlled in the safety and effectiveness ranges specified by relevant FDA guidance's. Testing has been carried out in very detailed and strictly. Test results and Risk Analysis show that the new unit Ultima NEO is safe with no any hazard.
Ultima NEO combines the systems of TENS, EMS, Micocurrent, and IF into one package, it is not possible to use any other system(s) simultaneously when one system is being used. Mechanical and electronical integrity ensures that only one system can be selected at any one time.
| Standard ORG | Standard Number | Standard Title |
|---|---|---|
| IEC | 60601 | Medical Electrical equipment- Part I: |
| IEC | 60601 - I -2 | Medical Electrical equipment- Part I-2: |
| IEC | 60601-1-4 | Medical Electrical equipment- Part I-4: |
| IEC | 60601-2-10 | Medical electrical equipment Part2 -10: |
| ISO | 14971 | Medical devices- |
| ISO | I 3485 | Medical Devices- |
| Quality Management systems- | ||
| IC council | 93/42/EEC | EC Directive 93/42/EEC Annex V, |
| Article 3, | ||
| IEC/EN | 62304 | IEC 62304 Ed. 1.0, |
| Medical device software |
5
| IEC-EN | 60601-1-6 | Medical electrical
equipment .Part I-6: |
|--------|-----------|--------------------------------------------|
| ISO | 9001 | Quality management
systems- |
| UL | 60601-1 | Medical electrical
equipment Part I : |
Conclusions:
The new device Ultima NEO, which includes TENS, EMS, MICrocurrent, and IF systems, has the same intended use and technological characteristics as the predicate devices of NMS-28 (K050921)/ MT9000 Combo TENS/EMS/IF/MIC (K093138) /GM3 Series IF TENS Model GM3X21F (K032719). Thus, the new device Ultima NEO is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pain Management Technologies c/o Mr. Joshua Lefkovitz President 1340 Home Avenue, Building A Akron, OH 44310
JUN - 5 2012
Re: K120054
Trade/Device Name: Ultima NEO Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, IPF, LIH Dated: May 18, 2012 Received: May 24, 2012
Dear Mr. Lefkovitz:
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. 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 (reporting of medical
7
Page 2 - Mr. Joshua Lefkovitz
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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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
8
510(k) Number : K120054
Device Name
: Ultima NEO
Indications for Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:
- Relaxation of muscle spasm; .
- Increasing local blood circulation and muscle re-education; ' .
- Prevention or retardation of disuse atrophy; .
- Prevention of venous thrombosis of the calf muscles immediately . after surgery;
- Maintaining or increasing range of motion. .
MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:
Symptomatic relief of chronic intractable pain. .
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
7
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Ophthalmic, Neurologiet ABAF effice of CDRH, Office of Device Evaluation (ODE) Nose and Throat Devices
510(k) Number.