(243 days)
Not Found
No
The summary describes a standard TENS/EMS device with adjustable parameters and pre-set modes, but there is no mention of AI, ML, or any features that would suggest adaptive or learning capabilities. The device description focuses on hardware features and basic electrical stimulation functions.
Yes
The device is indicated for providing symptomatic pain relief, relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining or increasing range of motion, all of which are considered therapeutic benefits.
No
The device is described as a TENS/PMS/EMS system used for symptomatic pain relief, muscle re-education, and other therapeutic purposes, not for diagnosing medical conditions.
No
The device description explicitly mentions hardware components such as a portable device, LCD display, dual output channels, AA batteries, and open circuit detectors.
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 stimulation, etc.) are all related to treating or managing conditions within the body through electrical stimulation. 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 with features for controlling the electrical output. This aligns 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, reagents, assays, or any other terms typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a therapeutic medical device, specifically an electrical stimulator, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device:
- TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
- For the EMS function, the NMS-28 is used for:
- Relaxation of muscle spasm
- Increasing local blood circulation
- 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
Device Description
For the TENS function A portable TENS device for pain relief.
For the EMS function
A portable EMS device for the re-education of muscles.
Features:
- Innovative design
- Large LCD display
- Dual output channels
- 2 AA Alkaline Batteries
- Adjustable frequency, pulse width, and timing parameters
- 9 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
§ 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 shows the word "EasyMed" in bold, black font. The word is underlined with a thin, black line. The background is white.
依士文电子仪器有限公司
vour suffering .
EasyMed Instrument Co.,Ltd
6
7
8
9
DEC I 2 2005
510(k) Summary
| Date of Summary prepared: | January 21, 2005 |
|---|---|
| Submitter: | EasyMed Instrument Co., Ltd |
| Address : | No.2 Bei Hai Da Rd Lunjiao, ShunDe, Foshan, Guangdong, China |
| Tel : | +86-757-27727282 27727283 |
| Fax : | +86-757-27727868 |
| E-Mail : | info@EasyMed.com.cn |
| Contact person: | Frances Lon (Long Shuming) |
Jeffery Wu (Wu Tingjie)
Address of the manufacturing facility: The same as above
Address of American Representative:
Norman F. Estrin, PhD, RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac MD 20854 U.S.A Tel: 001-301-279-2899 Fax: 001-301-294-0126
| Submitted Device: | |
|---|---|
| Generic name: | Powered Muscle Stimulator (PMS) (or Electrical Muscle Stimulator (EMS)) and Transcutaneous Electrical Nerve Stimulator (TENS) |
| Trade name: | EasySTIM NMS-28 |
| Common name: | For the TENS function—TENS device |
| For the EMS function—Powered Muscle Stimulators | |
| Classification name: | For TENS functions |
| Stimulator, Nerve, Transcutaneous, for Pain Relief - GZJ; | |
| 21 CFR 882.5890. |
1
Image /page/1/Picture/0 description: The image shows the word "EasyMed" in a bold, sans-serif font. The word is black and appears to be underlined. The letters are closely spaced, giving the word a compact appearance.
Easy for the relief of your suffering
EasyMed Instrument Co.,Ltd
For EMS functions Powered Muscle Stimulator for re-education of muscles - IPF;
21 CFR 890.5850
Device Classification: For both TENS & EMS functions - Class II
Predicate Device: For the TENS function EasyMed TENS Unit TN-28C (K040253) For the EMS function TensCare Ultima NMS/EMS Model XL-A3 - (K023997)
The class of the predicate Device:
Class II
Device Description:
For the TENS function A portable TENS device for pain relief.
For the EMS function
A portable EMS device for the re-education of muscles.
Features:
· Innovative design
· Large LCD display
• Dual output channels
• 2 AA Alkaline Batteries
· Adjustable frequency, pulse width, and timing parameters
• 9 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. This TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
-
For the EMS function, the NMS-28 is used for:
· Relaxation of muscle spasm
•Increasing local blood circulation
· Muscle re-education
· Prevention or retardation of disuse atrophy
2
Image /page/2/Picture/0 description: The image shows the word "EasyMed" in bold, black font. The word is split into two parts: "Easy" and "Med". A horizontal line underlines the entire word, emphasizing the brand name. The font is sans-serif and appears to be a logo or brand identifier.
依士文电子仪器有限公司
EasyMed Instrument Co.,Ltd suffering
•Prevention of venous thrombosis of the calf muscles immediately after surgery
· Maintaining or increasing range of motion
The intended use and indications for use of the new device are the same with that of the predicate devices.
Technological Comparison:
-
- The marketed device EasyMed TN-28C (K040253) is a digital TENS unit which has been well exploited the digital technology, supplying the user with full ranges of parameters, traditional TENS functions, and non-traditional new functions to be selected.
-
- In assembly, except software, the new device NMS-28 is exactly the same with the marketed device TN-28C, they have the same enclosure, the same circuit diagram, the same PCB layout, the same components and the same working principle;
-
- The marketed device TensCare Ultima NMS/EMS Model XL-A3 -(K023997) combines the functions of a TENS device and an EMS (Electrical Muscle Stimulator) or Powered Muscle Stimulator, into one package. It is also a digital unit with similar electronic working principle with TN-28C.
- The new device NMS-28 also combines the functions of a TENS ধ device and an EMS into one package. It is also substantial equivalent to the marketed device TensCare Ultima NMS/EMS Model XL-A3 - (K023997), their features and performances in muscle controlling as well as pain relief therapy are very similar substantially.
-
- The software of the new device NMS-28 can be divided into two parts: one for TENS function, the another for EMS function. The part of software for TENS function of the new device NMS-28 is only a subset of that of the marketed device TN-28C, what is more,
- the considerations on safety and reliability in TN-28C are also introduced into the EMS function of the new device; While the part of software for EMS function of the new device NMS-28 is very similar to that of the marketed device TensCare Ultima NMS/EMS Model XL-A3, by applying the similar control methods for muscle contraction-relaxation.
- The accessories of the new device NMS-28 are almost the same ్.
3
Image /page/3/Picture/0 description: The image shows the word "EasyMed" in a bold, sans-serif font. The letters are black, and there is a black line underneath the entire word. The word is likely a logo or brand name.
Easy for the relief of your suffering
EasyMed Instrument Co.,Ltd
with those of the marketed device TN-28C, and substantially equivalent to marketed device TensCare Ultima NMS/EMS Model XL-A3.
The Labeling is substantially equivalent to that of the predicate Labeling Comparison: devices.
Safety information:
Design to comply with relevant safety applicable recognized consensus standards; the output energy is well controlled in the safety and effectiveness ranges specified by relevant FDA guidance's. Testing has been carried out in very detailed and strict. · Test results, Risk Analysis, and FMEA analysis show that the new unit NMS-28 is safe with no any hazard.
NMS-28 combines the functions of TENS and EMS into one package, it is not possible to use the TENS and the EMS functions simultaneously. Mechanical integrity ensures that only one function can be selected at any one time.
NMS-28 has been on the European Market for the past two years. During this time a review of Customer Complaints, Returned Product and the results of Post Market Feedback, has demonstrated that the product has performed as Intended, to it's Specified Requirements.
Submitted times: It is the first submission to FDA for this new device
Conclusions:
The NMS-28 EMS/TENS unit is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2005
Jeffrey Wu EasyMed Instrument Co., Ltd No. 2 Bei Hai Da Road LunJiao, ShunDe Guangdong, China
Re: K050921
K050921
Trade/Device Name: EasyMed EMS/TENS Model NMS-28 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Codes: IPF, GZJ Dated: June 17, 2005 Received: November 23, 2005
Dear Mr. Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 D(t), plenial is substant for the indications for the indications for referenced above and have delemined the devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicate or to devices that use stated in the enclosure) to tegally hiar Recol prece Amendments, or to devices that prior to May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMA) You may. have been reclassified in accordance with the provisions of the Act. The Act. The peneral Act (Act) that do not require approval or a prematic controls provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of therefore, market the device, subject to the general on annual registration, listing of devices, good
controls provisions of the Act include requirements for anning mind and controls provisions of the Act mende requirements for and adulteration.
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 If your device is classified (see above) into cliffer the stime aftecting your device can be
may be subject to such additional controls. Existing major regulations FDA may may be subject to such additions, Title 21, Parts 800 to 898 . In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . found in the Code of Federal resganaties in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issualice of a substance requirements of the Act or any
FDA has made a determination that your device complex . You must comply with all FDA has made a determination inal your tee lice concess. You must comply with all
Federal statutes and regulations administerial and listing (21 CFR Part 807); Federal statutes and regulations administered or our registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration as set the Act s requirements, melading, but not maring practice requirements as set
labeling (21 CFR Part 801); good manufactures (200); and if annlice labeling (2) CFR Part 801); good inaliation (2) CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k)
. It is a legin and the first of a local started assissalence of your device to This letter will allow you to begin marketing your device as assisted by and one of your device to a legally
5
Page 2 -- Mr. Jeffrey Wu
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs of the many of the many of 10, 2019 - Alancy lass mote the regulation e If you desire specific advice for your de vice on on our nooning note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regul contact the Office of Compilance at (240) 210 of 2019 Part 807.97). You may obtain other "Misbranding by reference to premaired nother the Act from the Division of Small Manufactures,
general information on your responsibilities under the Act 1 - 1000 - 3301 May general information on your responsionities under (800) 638-2041 or (301) 443-6597 or
International and Consumer Assistance at is this and works of the l international and Consumer Treaver Tra.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
·· K050921 510(k) Number
EasyMed EMS/TENS Model NMS-28 Device Name :
Indications for Use :
TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain.
PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for:
- · Relaxation of muscle spasm
- · Increasing local blood circulation
- 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
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
page 1/1
Page 9 of 205
510(k) Number K050421