Ova+ (K-OVAP-USA)

K230926 · Tenscare, Ltd. · NUH · Dec 15, 2023 · Neurology

Device Facts

• Record ID: K230926
• Device Name: Ova+ (K-OVAP-USA)
• Applicant: Tenscare, Ltd.
• Product Code: NUH · Neurology
• Decision Date: Dec 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication. For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. The Ova+ is intended for use in the home. lt should be used only by women aged 18 and above.

Device Story

Ova+ is a battery-powered, single-channel Transcutaneous Electrical Nerve Stimulator (TENS) for home use. It delivers electrical stimulation to superficial nerves via self-adhesive electrodes placed on intact skin. The device features four preset treatment modes controlled by manual push-buttons. It is designed to be worn under clothing to provide continuous, drug-free pain relief. The user selects the mode and intensity; the device provides electrical pulses to modulate pain perception. It benefits patients by offering a non-invasive, portable option for managing menstrual and musculoskeletal pain. The device is intended for use by women aged 18 and older.

Clinical Evidence

No clinical testing performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, EMC, and software verification, alongside a usability study conducted per ISO 62366.

Technological Characteristics

Battery-powered (3.7V Li-Ion) TENS unit. Materials: ABS plastic, silicone. Output: Biphasic, rectangular waveform. Connectivity: Wired electrodes (2mm pins). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304, ISO 14971, IEC 60601-1-6, IEC 62366-1. Software: Microprocessor-controlled, verified per IEC 62304.

Indications for Use

Indicated for women aged 18+ for temporary relief of dysmenorrhea (menstrual cramps) when used with OTC pain medication (Mode 0) and temporary relief of sore/aching muscles in shoulder, waist, back, neck, arms, and legs due to exercise or household strain (Modes 1-3).

Regulatory Classification

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.

Predicate Devices

• Livia (K183110)
• Perfect EMS_OTC (K200694)

Reference Devices

• E-CM5090 electrodes (K210448)

Submission Summary (Full Text)

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December 15, 2023

TensCare Ltd Saskia Eldridge-Hinmers Regulatory Affairs Associate 9 Blenheim Road Epsom, Surrey KT19 9BE United Kingdom

Re: K230926

Trade/Device Name: Ova+ (K-OVAP-USA) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: November 13, 2023 Received: November 13, 2023

Dear Saskia Eldridge-Hinmers:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Doe W. Kumsa -S

for Pamela Scott, MS Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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) K230926

Device Name Ova+ (K-OVAP-USA)

Indications for Use (Describe)

For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medication.

For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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The Queen's Award
For Enterprise:
International
Trade 2021

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TensCare LTD. PainAway House 9 Blenheim Road Longmead Business Park Epsom, Surrey, KT19 9BE United Kingdom

## 510(k) SUMMARY

## 1. Submitters Identification

| Submitter: | TensCare Ltd |
|------------------------------------|-------------------------------------------------------------|
| Address: | 9 Blenheim Road, Epsom,<br>Surrey, KT19 9BE, United Kingdom |
| Tel : | [phone] |
| Fax : | [phone] |
| FDA Establishment Registration No: | 3003446042 |

| Contact person: | Saskia Eldridge-Hinmers |
|-----------------|----------------------------------------|
| | Regulatory Affairs Associate |
| Contact Phone: | [phone] |
| Contact Email: | [e-mail] |
| Date Prepared: | 15th November 2022 |

### Address of the manufacturing facility:

EasyMed Instruments Co Ltd 3/F, 5F/6F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, China,

FDA Establishment Registration No: 3004049909

### Address of American Representative:

| Contact First Name; | SCOTT A |
|---------------------|-----------------------------------------------------------------------|
| Contact Last Name: | BEDNAR |
| Title: | MR |
| Business Name: | QA/RA CONSULTING GROUP, INC. Full |
| Address: | 3335 TUSCARAWAS ROAD<br>BEAVER , PENNSYLVANIA , 15009 , UNITED STATES |
| E-mail: | [e-mail] |
| Phone Number: | 412 -4188066 |

Tenscare Ltd., Traditional 510(k) Ova+

18-11-2021

tenscare.co.uk [phone] [e-mail]

TENSCARE LTD IS AN EMPLOYEE OWNED BUSINESS MANAGING DIRECTOR - N.C. WRIGHT, SALES DIRECTOR - E.G. SLAVOVA, FINANCE DIRECTOR - C.S.K. SMITH. REGISTERED ADDRESS AS SHOWN ABOVE REGISTERED IN ENGLAND NO. 02839925.

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## 2. Subject Device

| Manufacturer | : Tenscare Limited |
|----------------------------|--------------------------------------------------------------|
| Trade/Device Name | : Ova+ (K-OVAP-USA) |
| 510(k) Number | : K230926 |
| Device Classification Name | : Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Common Name: | : Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification Name | : Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| CFR Regulation Number | : 21 CFR 882.5890 |
| Product Code | : NUH |
| FDA Device Classification | : Class II Medical Device |
| Device Type ID | : 3755 |
| Device Definition | : TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING<br>MUSCLES |

## 3. Predicate Devices

### 3.1. Primary Predicate Device

| Manufacturer | :Life Care Limited. |
|----------------------------|-------------------------------------------------------------|
| Trade/Device Name | :Livia |
| 510(k) Number | :K183110 |
| Device Classification Name | :Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Regulation Description | :Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| CFR Regulation Number | :21 CFR 882.5890 |
| Product Code | :NUH |
| FDA Device Classification | :Class II Medical Device |
| Device Type ID | 3755 |
| Device Definition | : TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING<br>MUSCLES |

### 3.2. Secondary Predicate Device

| Manufacturer | :TensCare Ltd |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name | :Perfect EMS_OTC |
| 510(k) Number | :K200694 |
| Device Classification Name | :Stimulator, Nerve, Transcutaneous,<br>Over-the-counter, Powered muscle stimulator |
| Regulation Description | :Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| CFR Regulation Number | :21 CFR 882.5890 |
| Product Code | :NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter<br>NGX (Stimulator, Muscle, Powered, For Muscle Conditioning |
| Classification Panel: | Neurology; Physical Medicine |
| FDA Device Classification | :Class II Medical Device |

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## 4. Device Description

The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle.

The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS).

The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients' intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves.

The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova+ is easily controlled by the end user using manual, push-button controls.

The new device Ova+ uses the same technical principle and substantially equivalent stimulation parameters to the marketed device Livia (K183110) and/or reference predicate device Perfect EMS (K200694)

The Ova+ uses a rechargeable Li-Ion polymer battery and a custom TENS connecting lead with 2mm connecting pins.

The Ova+ is supplied with adhesive electrodes that are similar to those of the predicate devices.

## 5. Indication For Use/Intended Use

For Mode 0, Ova+ is indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.

For Modes 1, 2& 3 Ova+ is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

### Intended Use

The Ova+ is intended for use in the home. lt should be used only by women aged 18 and above.

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## 6. Indication for Use comparison

| Characteristic | New Device<br>Ova+ | Primary Predicate<br>Device<br>Livia | Secondary Predicate<br>Device Perfect EMS<br>OTC | |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Manufacturer | Tenscare Limited | Life Care Ltd. | TensCare Ltd | |
| 510(k) No. | K230926 | K183110 | K200694 | |
| Indications for<br>Use | For Mode 0, Ova+ is<br>indicated for temporary<br>relief of pain associated<br>with dysmenorrhea<br>(menstrual cramps) when<br>used with over-the-<br>counter pain medication.<br>For Modes 1, 2& 3 Ova+<br>is indicated for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm) and<br>lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household work activities. | The Livia is designed for<br>symptomatic relief and<br>management of chronic<br>pain, and for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, neck, upper<br>extremities (arm) and<br>lower (extremities) leg<br>due to strain from<br>exercise or normal<br>household work activities.<br>The Livia is also indicated<br>for temporary relief of<br>pain associated with<br>dysmenorrhea (menstrual<br>cramps) when used with<br>over-the-counter pain<br>medication. | TENS: The device is<br>designed to be used<br>for temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm),<br>lower extremities (leg),<br>abdomen and bottom<br>due to strain from<br>exercise or normal<br>household work<br>activities | |
| Intended Users | The Ova+ is intended for<br>use in the home.<br>It should be used only by<br>women aged 18 and<br>above. | Livia should be used only<br>by women aged 18 and<br>above. | Keep away from<br>children | |
| Class | ll | ll | ll | |
| Product code | NUH | NUH | NUH | |
| Regulation number | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | |
| OTC Use | Yes | Yes | Yes | |
| Single Use or<br>Reusable | Reusable<br>For single patient use | Reusable<br>For single patient use | Reusable<br>For single patient use | |
| Characteristic | New Device | Primary Predicate<br>Device | Secondary Predicate<br>Device | Comparison |
| Device<br>Name/Model | Ova+ | Livia | Perfect EMS | |
| 510(k) | K230926 | K183110 | K200694 | |
| Manufacturer | TensCare Ltd | LifeCare Ltd. | TensCare Ltd | |
| Power Source(s)1 | 3.7V Lithium ion<br>battery(rechargeable) | 3.7V Lithium ion<br>battery(rechargeable) | 2 x AA alkaline battery | Internal power<br>source<br>Substantially<br>Equivalent. |
| Method of Line<br>current Isolation | Not possible to<br>connect patient lead<br>and charger at same<br>time - use same<br>socket | Output is electrically<br>disabled when<br>connect to charger, by<br>means of<br>microprocessor<br>charging circuit | No connection to Line<br>Current | Substantially<br>Equivalent. |
| Patient Leakage<br>Current<br>- Normal Condition<br>(μΑ) | Battery<br>powered<br>(< 10μA) | Battery<br>powered<br>(< 10μA) | Battery<br>powered<br>(< 10μA) | Identical |
| Patient Leakage<br>Current<br>- Single Fault<br>Condition (μΑ) | Battery<br>powered<br>(< 50μA) | Battery<br>powered<br>(< 50μA) | Battery<br>powered<br>(< 50μA) | Identical |
| Average DC current<br>through Electrodes<br>when device is on<br>but<br>no pulses are being<br>applied (μΑ) | 0 µA | 0 µA | 0 µA | Identical with<br>primary<br>predicate |
| Number of Output<br>Modes | 4<br>1 Dysmenorrhea &<br>3 Pain | 1 Dysmenorrhea | 1 Pain | Substantially<br>equivalent |
| Number of Output<br>Channels | 1 | 1 | 2 | Identical with<br>primary<br>predicate |
| Regulated Current<br>or Voltage? | Voltage | Current | Voltage | Substantially<br>Equivalent. |
| Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | Identical |
| Automatic No-Load<br>Trip? | No | Yes | Yes | Substantially<br>Equivalent. |
| Automatic Overload<br>Trip? | No | Yes | Yes | Substantially<br>Equivalent. |
| Automatic Shut Off? | No | No | Yes | Identical |
| Characteristic | New Device | Primary Predicate<br>Device | Secondary Predicate<br>Device | Comparison |
| Device<br>Name/Model | Ova+ | Livia | Perfect EMS | |
| User Override<br>Control? | Yes | Yes | Yes | Substantially<br>Equivalent. |
| Indicator Display:<br>-On/Off status<br>-Low battery<br>-Voltage/Current<br>level<br>-Time to cut-off | Yes<br>Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes<br>Yes | Identical |
| Timer Range<br>(minutes) | No Timer | The Livia has no<br>internal timer | 20-40 | Identical with<br>primary<br>predicate |
| Compliance with<br>Voluntary<br>Standards? | IEC 60601-1,<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11<br>IEC 62304<br>ISO 14971<br>IEC 60601-1-6<br>IEC 62366-1 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10,<br>ISO 10993-1, -5 and -<br>10 | IEC 60601-1:2005<br>IEC 60601-1-2<br>IEC 60601-2-10 IEC<br>60601-1-11<br>IEC 62304<br>ISO 14971 | Substantially<br>Equivalent. |
| Compliance with 21<br>CFR 898? | Yes | Yes | Yes | Identical |
| Weight g | 19.5 | 37 | 146.5 | Similar |
| Dimensions (mm) | 65 x 38 x 10 | 55X 55 X 20 | 66×136×30.7 | Similar |
| Housing Materials<br>and Construction | Silicone, ABS<br>plastics | ABS plastics | ABS plastics | Substantially<br>Equivalent. |
| Sterilization | N/A | N/A | N/A | Identical |
| Parameter | New Device | Primary Predicate<br>Device | Secondary<br>Predicate<br>Device | Comparison |
| Device<br>Name/Model | Ova+ | Livia | Perfect EMS<br>OTC | |
| 510(k) | K230926 | K183110 | K200694 | |
| Manufacturer | TensCare Ltd | LifeCare Ltd. | TensCare Ltd | |
| Waveform | Biphasic,<br>Equal duration…