(184 days)
Not Found
No
The summary describes a basic electrical muscle stimulator with no mention of AI or ML capabilities, data processing, or performance studies related to algorithmic output.
No
The device explicitly states "Not intended for use in any therapy or for the treatment of any medical conditions or diseases."
No
The "Intended Use / Indications for Use" section explicitly states that these devices are "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," which implies they are not for diagnosing conditions. Their purpose is for muscle stimulation and improvement, not diagnosis.
No
The device description explicitly states that the device comprises an "electronic stimulator module" and "electrodes," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "improvement of muscle tone and firmness, for strengthening muscles... Not intended for use in any therapy or for the treatment of any medical conditions or diseases." IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening of diseases or conditions. This device does not perform such analysis.
- Device Description: The description details an electrical muscle stimulation unit that applies signals to the skin to exercise muscles. This is a physical intervention, not an in vitro analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a physical therapy or exercise device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Product codes
NGX
Device Description
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms, abdomen, thighs, and buttocks areas
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, connected by flowing lines that resemble ribbons or streams. The profiles are arranged in a staggered formation, with the first profile being the largest and the subsequent profiles gradually decreasing in size. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
HIVOX BIOTEK, INC. Ke-Min Jen. Official Correspondent 5 F., No. 123 Shingde Road San-chong District New Taipei City. TW 24158
Re: K141921
Trade/Device Name: HIVOX Spopad EMS SP-910, SP-920, SP-620 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 7, 2014 Received: December 11, 2014
Dear Dr. Jen. Ke-Min:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141921
Device Name HIVOX Spopad EMS SP-910, SP-920, SP-620
Indications for Use (Describe)
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the word "HIVOX" in a sans-serif font. The letters are black, and there is a registered trademark symbol after the "X". To the right of the word is a plus sign made up of four squares. The top left square is green, and the bottom right square is blue.
5. 510(k) SUMMARY (According to 21 CFR 807.92)
| ● | 510(K) OWNER'S
HIVOX BIOTEK INC. | |
|---|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAME | 5F, No.123, Shingde Road, Sanchong Dist.,
New Taipei City, 24158, TAIWAN, R.O.C. |
| | | TEL: +886-2-85112668 FAX:+886-2-85112669 |
| ● | Name Of Contact
Person | Dr. JEN, KE-MIN
TEL: 886-2-85112668 FAX:886-3-5209783
Email: ceirs.jen@msa.hinet.net |
| ● | Date Of Submission | July 5, 2014 |
| ● | Trade Name | HIVOX Spopad EMS SP-910, SP-920, SP-620 |
| ● | Common Name | Powered Muscle Stimulator |
| ● | Classification Name | Powered Muscle Stimulator
(21 CFR 890.5850, Product Code NGX) |
| ● | Panel | Physical Medicine |
| ● | Intended Use | These Electrical Muscle Stimulation units are indicated for the
improvement of muscle tone and firmness, for strengthening
muscles in arms, abdomen, thighs, and buttocks areas.
Not intended for use in any therapy or for the treatment of any
medical conditions or diseases. |
| ● | Device Design | EMS, Electrical Muscle Stimulation, which improves, tones,
firms & strengthens muscle and relaxes stiff muscle through the
skin. It is recognized as a clinically proven, effective,
non-medication method of training muscle from certain causes.
It manages muscle strengthen, toning and firming. It is also free
from side effects when used properly, and can also be used as a
simple means of self-training. |
HIVOX Spopad EMS SP series, SP-910 / SP-920 / SP-620 are the proposed subject devices for this 510(k) submission.
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Image /page/4/Picture/0 description: The image shows the word "HIVOX" in bold, black letters. To the right of the word is a plus sign made up of four squares. The top left and bottom right squares are green, and the top right and bottom left squares are blue.
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.
5
5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669
| Comparison items | Predicate device 1
(PD) | Subject device
(1) | Subject device
(2) | Subject device
(3) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|
| Manufacturer
Submitter | SPORT-ELEC S.A. | HIVOX-BIOTEK | | |
| Device name | Body Control
System | Spopad EMS, SP series | | |
| Model number | 4M | SP-910 | SP-920 | SP-620 |
| 510(k) number | K092476 | TBA | TBA | TBA |
| Product code | NGX | | NGX | |
| Classification name | Powered Muscle
Stimulator | Powered Muscle Stimulator | | |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | | |
| Indications for use | Indicated for the
improvement of
muscle tone and
firmness, for
strengthening
muscles in arms,
abdomen, thighs
and buttocks areas.
Contraindicated
use on injured or
otherwise impaired
muscles
Not intended for
use in any therapy
or for the treatment
of any medical
conditions or
diseases. | Indicated for the improvement of muscle tone
and firmness, for strengthening muscles in arms,
abdomen, thighs, and buttocks areas.
Not intended for use in any therapy or for the
treatment of any medical conditions or diseases. | | |
| Technology | Electrical Muscle
Stimulation | Electrical Muscle Stimulation | | |
| Power Source | 1.5V battery *3 | 3V Battery *1 | | |
| - Method of Line
Current Isolation | Battery supply | Battery Supply | | |
| - Patient Leakage
Current
Normal Condition (µA) |