(371 days)
Not Found
No
The description details a standard electrical muscle stimulator with pre-set programs and adjustable intensity, with no mention of adaptive algorithms, learning capabilities, or data processing that would indicate AI/ML.
Yes
The device is described as a "neuromuscular electronic stimulator intended for medical purposes" and lists several therapeutic indications, such as "Prevention or retardation of muscle disuse atrophy" and "Relaxation of muscle spasm."
No.
The device description and intended use clearly state that the FD EMS is a muscle stimulator used for therapeutic purposes, such as preventing muscle atrophy, relaxing spasms, and increasing circulation. It generates electrical pulses to contract muscles; it does not analyze or interpret physiological data to diagnose a condition.
No
The device description explicitly states it is a "handheld battery powered EMS device" that "generate[s] electrical pulses and transmit[s] it to the electrodes," indicating it is a physical 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- FD EMS Function: The FD EMS is a neuromuscular electronic stimulator. It works by applying electrical currents directly to the body through electrodes on the skin to stimulate muscles. This is an in vivo (within the living body) application, not an in vitro test.
- Intended Use: The intended uses listed are all related to directly affecting muscles and circulation within the body, not analyzing biological samples.
Therefore, based on the provided information, the FD EMS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use:
- Prevention or retardation of muscle disuse atrophy.
- Relaxation of muscle spasm.
- Muscle re-education.
- Maintaining or increasing range of motion.
- Increasing local blood circulation.
- Immediate post-surgical of calf muscle to prevent venous thrombosis.
Product codes
IPF
Device Description
The FD EMS is a handheld battery powered EMS device, which is used for muscle stimulation. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the skin of patient. Consequently, the electrical pulses would then pass through the skin to nerves of the muscle and cause the muscle to expand and contract.
FD EMS has two output channels and seven stimulation programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 15 steps.
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
Non-clinical Testing: Compliance to applicable voluntary standards includes EN 60601-1 and EN 60601-1-1 requirements. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced.
Key Metrics
Not Found
Predicate Device(s)
BMLS03-1 (K031427)
Reference Device(s)
Not Found
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
10 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Submitter's Identification 10.1
DEC 1 3 2007
Fuji Dynamics Ltd. Unit 1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road, Kowloon, Hong Kong Tel: (852) 2786 4218 Fax: (852) 2744 6775
Contact Person: Irene, Cheung Pui Lai Date Prepared: 26th Nov 2007
10.2 Name of Device:
Proprietary Name: FD EMS
Common or Usual Name: EMS unit
Classification Name: Physical Medicine Device - Physical Medicine Therapeutic Device - Power Muscle Stimulator (21 CFR 890.5850)
Device Classification: Class II
Predicate Device Information: 10.3
The FD EMS is equivalent to the BMLS03-1 (K031427).
10.4 Device Description:
The FD EMS is a handheld battery powered EMS device, which is used for muscle stimulation. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the skin of patient. Consequently, the electrical pulses would then pass through the skin to nerves of the muscle and cause the muscle to expand and contract.
1
FD EMS has two output channels and seven stimulation programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 15 steps.
10.5 Intended Use:
Indications for use:
- Prevention or retardation of muscle disuse atrophy.
- Relaxation of muscle spasm.
- Muscle re-education.
- Maintaining or increasing range of motion.
- Increasing local blood circulation.
- Immediate post-surgical of calf muscle to prevent venous thrombosis.
10.6 Technological Comparison to Predicate Device:
The FD EMS has basic technological characteristics that are substantially equivalent to the predicate device. Both devices are battery powered and have adjustable output amplitudes. Both the legally marketed predicate device and FD EMS is a two channels device. The only significant technological difference between the two devices is that FD EMS possesses an open-circuit detection feature. It means that FD EMS could check the continuity between the output terminals, and avoid increment of output in the absence of load.
All units use "shrouded patient cable connectors" to comply with the FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."
10.7 Non-clinical Testing:
Compliance to applicable voluntary standards includes EN 60601-1 and EN 60601-1-1 requirements.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
Clinical Testing 10.8
Not Applicable as there are no new or innovative aspects that have been introduced.
10.9 Conclusions:
The FD EMS has the same intended use and similar technical characteristics as the BMLS03-1 (K031427).
The information supplied in this 510(k) illustrates that the device do not pose any new
2
questions of safety and effectiveness. Therefore, the FD EMS is substantially equivalent to the predicate device.
:
:
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
DEC 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fuji Dynamics Ltd. % Ms. Irene Cheung Pui Lan Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon, Hong Kong
Re: K063642
Trade/Device Name: FD EMS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 1, 2007 Received: November 29, 2007
Dear Ms. Irene Cheung Pui Lan:
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 such 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); 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.
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Page 2 – Ms. Irene Cheung Pui Lan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix A-Indication For Use
510(k) Number (if known): K063642
Device Name: FD EMS
Indications for Use:
The FD EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Prevention or retardation of muscle disuse atrophy; -
- Relaxation of muscle spasm; .
- Muscle reeducation; ・
- Maintaining and increasing the range of motion; -
- Increasing local blood circulation; -
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
(Division Sign-Off)
Division of General, Restorat
and Neurological Devices
510(k) Number 1206362
Prescription Use X AND/OR Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)