ELECTROTHERAPY DEVICE (COMBO UNIT)

K130691 · Guangzhou Finecure Medical Equipment Co.,Ltd · IPF · Dec 20, 2013 · Physical Medicine

Device Facts

• Record ID: K130691
• Device Name: ELECTROTHERAPY DEVICE (COMBO UNIT)
• Applicant: Guangzhou Finecure Medical Equipment Co.,Ltd
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain. EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for: 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

Device Story

Electrotherapy Device (Combo Unit) Model 9612 provides TENS, EMS, and IF stimulation; delivers electrical impulses to nerves and muscles via electrodes; used in clinical or home settings under prescription; operator applies electrodes to patient skin; device settings adjusted to manage pain or stimulate muscle contraction; output affects nerve signaling and muscle physiology; benefits include pain reduction, improved circulation, and muscle rehabilitation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850); provides TENS, EMS, and IF stimulation modes; electrical energy source; Class II device.

Indications for Use

Indicated for patients requiring symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain (TENS/IF modes) and muscle stimulation for spasm relaxation, blood flow improvement, atrophy prevention, muscle re-education, range of motion maintenance, and post-surgical venous thrombosis prevention (EMS mode).

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 20, 2013

Guangzhou Finecure Medical Equipment Co., Ltd. c/o Field Fu Shenzhen ZYTC Consulting Co., Ltd. 05C Fuhai Kangle Building Nanshan District, Shenzhen China 518000

Re: K 130691

Trade Name: Electrotherapy Device (Combo Unit) Model 9612 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: October 4, 2013 Received: November 5, 2013

Dear Mr. Fu:

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

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Page 2 - Mr. Field Fu

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Joyce M. Whang -S

for Carlos L. Peña, PhD Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130691

Device Name: Electrotherapy Device (Combo Unit) Model 9612

Indications For Use:

TENS stands for Transcutaneous Electrical Nerve Stimulation. The device TENS system is used to provide Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

EMS stands for Electrical Neuromuscular Stimulator. The device EMS system is indicated for:

- 1. Relaxation of muscle spasm.
- 2. Increase of local blood flow circulation
- 3. Prevention or retardation of disuse atrophy
- 4. Muscle re-education
- 5. Maintaining or increasing range of motion.

6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

IF stands for Interferential Stimulation. The device IF system is indicated for Symptomatic relief of chronic intractable pain, Post traumatic pain and Post surgical pain.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

## Joyce M. Whang -S

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