(80 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The intended uses are standard for electrical muscle stimulation devices.
Yes
The device is indicated for therapeutic purposes such as "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," and "Increasing local blood circulation."
No
The document describes the intended uses of the device, which are all therapeutic (e.g., "Relaxation of muscle spasms", "Prevention or retardation of disuse atrophy", "Increasing local blood circulation", "Muscle re-education"). There is no mention of the device being used to identify or diagnose any medical condition.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use indicates therapeutic applications typically associated with hardware devices (e.g., muscle stimulation), but without a description, it's impossible to confirm.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses (relaxation of muscle spasms, prevention of disuse atrophy, increasing blood circulation, etc.) are all related to physical therapy and rehabilitation, acting directly on the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Any laboratory or diagnostic procedures.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The intended uses described here clearly fall outside of this definition.
N/A
Intended Use / Indications for Use
For model FS-004
- Relaxation of muscle spasms
For models FS-008, FS-012, FS-016 and FS-020 - Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes
IPF
Device Description
Not Found
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
Finesun Worldwide Int'l Co., Ltd. % Chi-Chu Wu Chen New Century Technology 3F, No. 31, Hu-Pin Road #1 Hsin-Chu, Taiwan
Re: K020684
Trade/Device Name: Finesun EMS Stimulator, Models FS-004, FS-008, FS-012, FS-016 and FS-020 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: February 27, 2002 Received: March 4, 2002
Dear Mr. Chen:
This letter corrects our substantially equivalent letter of May 23, 2002.
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 for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered prox to 110 - 110 - 120 - 120 - 12 - 12 - 11 - 11 - 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 r ou may attress, and include requirements for annual registration, listing of general controls provision 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 ir your device to such additional controls. Existing major regulations affecting your device can may be subject to back as one as a may be marts 800 to 898. In addition, FDA may be round in ther over ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actives and I Drivision that your device complies with other requirements of the Act that 1 Dr Has Intactions and regulations administered by other Federal agencies. You must or any I edelar status and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 007); idocime (21 CFR Part 820); and if applicable, the electronic form in the quany by overs of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 -- Chi-Chu Wu Chen
This letter will allow you to continue 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
2
3.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if know)
Finesun EMS Stimulator Device Name
Indications for Use:
For model FS-004
-
Relaxation of muscle spasms ●
For models FS-008, FS-012, FS-016 and FS-020 -
Relaxation of muscle spasms .
-
Prevention or retardation of disuse atrophy .
-
Increasing local blood circulation ●
-
Muscle re-education ●
-
Immediate post-surgical stimulation of calf muscles . to prevent venous thrombosis
-
Maintaining or increasing range of motion .
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use (Per 21 CFR 801.109) Over -The-Counter Use_
for Mark N. Milken
(Division Sign Off)
ion of General, Restorative Neurological Devices
510(k) Number K020684