(213 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrotherapy and app control without mentioning any AI/ML capabilities.
Yes
The device is intended for the temporary relief and management of pain associated with sore and aching muscles, chronic pain, and arthritis, all of which are conditions that therapeutic devices aim to treat or alleviate.
No
The device is described as an electrotherapy device designed for "temporary relief of pain" and "symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis." It delivers microcurrent therapy for pain relief and management, rather than identifying or diagnosing a medical condition.
No
The device description explicitly states it is a "single channel wearable electrotherapy device" and includes hardware components like a rechargeable unit, cables, and electrodes, in addition to the software app.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief and management of pain associated with muscles and joints. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a wearable electrotherapy device that delivers microcurrent therapy through electrodes applied to the skin. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a therapeutic device used for pain relief, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NYN
Device Description
The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body.
The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls. The Healy will be packaged with an Instruction Manual and quick start guide that provides details on setting up the device for use, installing of the App, setting and controlling therapy modes, and troubleshooting. The system includes the unit, adhesive gel electrodes, USB charging cable, electrode connection cable, and storage case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, arms and legs.
Indicated Patient Age Range
All adults 18 years and older.
Intended User / Care Setting
Clinics, hospital and home environments.
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)
All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended.
Nonclinical Testing Summary:
The nonclinical, bench testing included performance verification to confirm acceptable performance of device features and functions. Other nonclinical safety testing included:
- · Electrical safety and electromagnetic compatibility testing
- · Software verification and validation
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Healy meet the established specifications.
Performance Data: Electromagnetic Compatibility and Electrical Safety
The Healy device has been thoroughly tested against applicable EN and IEC standards by a third p arty and found to be in compliance with the applicable sections. It was functionally tested and found to be in compliance with the specification.
The applicable electrical and safety standards met are:
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
EN 301 489-1 &17: Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment
TCRL 2015-2: Bluetooth RF Compliance
Software Validation
The Healy device software was validated following FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
The applicable software validation standards met are: EN 62304 Medical device software - Software life cycle processes EN ISO 13485: 2012 Medical devices-Quality management systems-Requirements for regulatory purposes EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices EN 62304: 2006 Medical device software - Software life cycle processes EN 62366: 2008 Medical devices - Application of usability engineering to medical devices
Biocompatibility Data
Biocompatibility testing is not required because the only patient contact surface is through the electrode which was previously cleared by FDA.
Non-Clinical Testing - Other
In addition to electrical safety testing and software validation, human factors analysis and testing was also conducted and no user issues were identified.
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.
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
TimeWaver Production GmbH % Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave, SW #43083 Grandville, Michigan 49418
Re: K191075
Trade/Device Name: Healy Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NYN Dated: October 30, 2019 Received: November 12, 2019
Dear Douglas Herrington:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191075
Device Name Healy
Indications for Use (Describe)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K191075
General Information
Date: May 26, 2019
Applicant & Manufacturing Address:
TimeWaver Production GmbH Schloss Kränzlin, Darritzer Straße 6 Kränzlin, Germany 16818 Phone: +49-3391-40022-11 FAX: +49-3391-40022-99 Registration Number: 3009411292
Contact Name
Douglas Herrington Principal Consultant Herrington Consulting LLC 2885 Sanford Ave SW#43083 Grandville, MI 49418-1342 Telephone: 1.248.369.5564 Fax: 1.877.881.4412 E-mail: dgls herrington@yahoo.com
Regulatory Information
Device Name: Healy 510(K) Number: K191075 Classification: Class II Panel: Neurological Therapeutic Devices Product Code: NUH, NYN Regulation Number: 21 CFR 882.5890, Transcutaneous electrical nerve stimulator for pain relief
Indication for Use Statement
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities. And for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Environments of Use: Clinics, hospital and home environments.
Patient Population: All adults 18 years and older.
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510(k) Summary: K191075
Substantial Equivalence Summary
| Table 1: Substantial | |||
|---|---|---|---|
| Equivalence Comparison Table | Microcurrent | Microcurrent | Comparison |
| 510(k) Number | K191075 | K172079 | |
| Regulation | 21 CFR§882.5890 | 21 CFR§882.5890 | No Difference |
| Product Code | NUH, NYN | NUH | Similar, Healy adds product code |
| NYN, however Omron's IFU states | |||
| arthritis pain treatment but the 510k | |||
| approval is for only NUH. | |||
| Device Name | Healy | Avail, Model PM601 | |
| Manufacturer | TimeWaver Production GmbH | Omron Healthcare Inc | |
| Usage | Over the Counter | Over the Counter | No Difference |
| Intended Use | The Healy is intended for the relief | ||
| of pain associated with sore or | |||
| aching muscles of the lower back, | |||
| arms, legs, shoulders or feet due to | |||
| strain from exercise or normal | |||
| household work activities. | |||
| For the symptomatic relief and | |||
| management of chronic, intractable | |||
| pain and relief of pain associated | |||
| with arthritis. | The Avail is intended for the relief | ||
| of pain associated with sore or | |||
| aching muscles of the lower back, | |||
| arms, legs, shoulders or feet due to | |||
| strain from exercise or normal | |||
| household work activities. | |||
| When used for the symptomatic | |||
| relief and management of chronic, | |||
| intractable pain and relief of pain | |||
| associated with arthritis, use the | |||
| Tap, Shoulder, Arm or Leg mode | |||
| of stimulation. | No Difference | ||
| Environment of Use | Environments of Use: Clinics, | ||
| hospital and home environments. | Environments of Use: Clinics, | ||
| hospital and home environments. | No Difference | ||
| Patient Population | Patient Population: All adults 18 | ||
| years and older. | Patient Population: All adults 18 | ||
| years and older. | No Difference | ||
| Contraindications/ | |||
| Warnings/ | |||
| Precautions | Contraindications: Do not use this | ||
| device if you have a cardiac | |||
| pacemaker, implanted defibrillator, | |||
| or other implanted metallic or | Contraindications: Do not use this | ||
| device if you have a cardiac | |||
| pacemaker, implanted defibrillator, | |||
| or other implanted metallic or | No Difference |
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510(k) Summary: TimeWaver Production GmbH
| electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | electronic device. Such use could cause electric shock, burns, electrical interference, or death. Patient-contacting Pads are for single patient use | No Difference | |
|---|---|---|---|
| Single Use | |||
| Sterility | External contacting device, nonsterile | External contacting device, nonsterile | No Difference |
| Over-the-Counter: (OTC) | Yes | Yes | No Difference |
| Power Source: Voltage | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | No Difference |
| Method of Line Current Isolation | N/A (internal power source) | N/A (internal power source) | No Difference |
| Patient Leakage Current | |||
| -normal Condition, uA | 0 |