(51 days)
Not Found
No
The device description focuses on manual control of parameters via buttons and adjustable settings, with no mention of automated learning or adaptive algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as an electrical nerve stimulator for pain relief (TENS) and an electrically powered muscle stimulator (EMS) for various medical purposes, which are therapeutic functions.
No
The device is an electrical nerve stimulator (TENS) and/or an electrical muscle stimulator (EMS) used for pain relief, muscle stimulation, and management of various musculoskeletal issues by applying electrical currents, not for diagnosing conditions.
No
The device description explicitly states that the device is an electrical nerve stimulator and/or electrical muscle stimulator that sends electrical current via electrodes applied to the skin. This indicates a physical hardware component that delivers the electrical stimulation, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The description clearly states that this device is a Transcutaneous Electrical Nerve Stimulator (TENS) and/or Electrical Muscle Stimulator (EMS). It works by applying electrical current to electrodes on the patient's skin to stimulate nerves and muscles.
- Intended Use: The intended use is for pain relief and muscle stimulation, which are therapeutic applications, not diagnostic testing of biological samples.
The device operates externally on the body and does not involve the analysis of samples taken from the body.
N/A
Intended Use / Indications for Use
The intended Use of Comfy TENS, Model EV-804 TENS is as follows: This device is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
The Intended Use of Comfy EMS, Model EV-805 EMS is as follows: This device is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation. (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
The Intended Use of Comfy Stim, Model EV-806 TENS/EMS Combination Unit are as follows: This combination device is intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
It is also intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
Product codes
IPF, GZJ
Device Description
The Comfy Series, which includes models EV-804, EV-805, EV-806, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liguid crystal display and parameters for patients to create their own settings.
The EV-804 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EV-805 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The EV-806 is a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of EV-804 and EV-805. The difference on the three units can be identified by the liquid crystal display.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
K07/951/
SEP - 5 2007
510(k) Summary As Required by 21 section 807.92 ( c )
- Everyway Medical Instruments Co., Ltd 1-Submitter Name: 3 FL., No.5, LANE 155, Sec. 3, Peishen Rd 2-Address: Shen Keng Hsiang. 222 Taipei Hsien. Taiwan (ROC) (886) 2 2662 0038
- 3-Phone: (886) 2 2664 5566
- 4-Fax:
Mr Robert Tu (General Manager) 5-Contact Person:
- 6-Date summary prepared: July 10th, 2007
- 7 Official Correspondent: Mansour Consulting LLC
- 8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA
- 9- Phone: 678-908-8180
- 10- Fax: 678-623-3765
- 11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name:
- (a) Comfy TENS (Model EV-804)
- (b) Comfy EMS (Model EV-805)
- (c) Comfy STIM (Model EV-806)
13-Device Common or usual name:
- (a) TENS UNIT
- (b) EMS UNIT
- (c) TENS/EMS COMBINATION UNIT
14-Device Classification Name:
- (a) Stimulator, nerve, transcutaneous, for pain relief
- (b) Stimulator, muscle, powered
- (c) Combination of (i) Stimulator, nerve, transcutaneous, for pain relief AND (ii) Stimulator, muscle, powered
- 15-Substantial Equivalency is claimed against the following device:
16-Description of the Device:
The Comfy Series, which includes models EV-804, EV-805, EV-806, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liguid crystal display and parameters for patients to create their own settings.
The EV-804 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EV-805 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The EV-806 is
1
a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of EV-804 and EV-805. The difference on the three units can be identified by the liquid crystal display.
17-Intended use of the device: (refer to FDA form attached)
The intended Use of Comfy TENS, Model EV-804 TENS is as follows:
This device is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
The Intended Use of Comfy EMS, Model EV-805 EMS is as follows:
This device is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation. (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
The Intended Use of Comfy Stim, Model EV-806 TENS/EMS Combination Unit are as follows:
This combination device is intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
It is also intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
18-Safety and Effectiveness of the device:
This series is safe and effective as the predicate devices cited above. The design modifications that EV-803 and EV-807 underwent did not affect safety and effectiveness of the new series EV-804, EV-805 and EV-806 as detailed within this submission.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everyway Medical Instruments Co., Ltd. C/O Jay Mansour President Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075
SEP - 5 2007
Re: K071951
Trade Name: Comfy Series, Models EV-804, EV-805, and EV-806 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF and GZJ Dated: August 10, 2007 Received: August 15, 2007
Dear Mr. Mansour:
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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Page 2 -- Mr. Jay Mansour
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. 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 vours.
Neil R. Oyler
J Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071951
Device Name: COMFY SERIES EV-804, EV-805 & EV-806
Indications For Use:
APPLICABLE FOR EV-804 (TENS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
APPLICABLE FOR EV-805 (EMS) AND EV-806 (TENS/EMS COMBINATION UNIT):
This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
V 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 CDRH, Office of Device Evaluation (ODE)
Neil RP Ogden for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number