Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

K211942 · Shenzhen Osto Technology Company Limited · NGX · Dec 13, 2021 · Physical Medicine

Device Facts

• Record ID: K211942
• Device Name: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
• Applicant: Shenzhen Osto Technology Company Limited
• Product Code: NGX · Physical Medicine
• Decision Date: Dec 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

Device Story

Portable TENS/PMS device with integrated heating; includes main unit, remote control, adapter, and electrode pads. Inputs: user-selected stimulation mode (5 modes) and heating level (3 levels: 37°C, 40°C, 43°C) via remote. Operation: main unit delivers electrical pulses to nerves (TENS) or muscles (PMS) via stainless steel plate or external electrode pads; heating provided by stainless steel plate. Used in home/clinic settings by patients. Output: electrical stimulation and heat to target muscles. Benefits: temporary pain relief, muscle conditioning, improved muscle performance. Healthcare providers use device output to manage minor aches/pains and muscle conditioning.

Clinical Evidence

Bench testing only. Device validated for electrical safety (IEC 60601-1, 60601-1-11, 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366), and biocompatibility (ISO 10993-5, 10993-10). Waveform output verified against FDA guidance for TENS and PMS devices.

Technological Characteristics

Materials: ABS plastic, stainless steel, silica gel, conductive silicone. Energy: 100-240VAC adapter (5Vdc output). Waveform: Symmetrical biphasic, rectangular. Connectivity: Wired remote control. Sterilization: N/A. Software: Microprocessor-controlled with 5 stimulation modes and 3 heating levels. Safety: Type BF applied part, automatic shut-off.

Indications for Use

Indicated for healthy adults experiencing sore/aching muscles in shoulder, waist, back, arm, or leg due to exercise or household strain; intended for muscle conditioning and temporary pain relief. Contraindicated for patients with medical conditions.

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.

Predicate Devices

• Health Expert Electronic Stimulator (AST-300L) (K190783)
• StimPlus Patch (K200561)

Submission Summary (Full Text)

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December 13, 2021

Shenzhen OSTO Technology Company Limited % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510663 China

Re: K211942

Trade/Device Name: Heating Lumbar Therapy Cushion (Model: AST-622, AST-623, AST-623B) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX, NUH, IRT Dated: December 6, 2021 Received: December 10, 2021

Dear Cassie Lee:

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 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 (QS) 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 medical devices and radiation-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).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K211942

Device Name

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

#### Indications for Use (Describe)

PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

| 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) <span style="text-decoration: overline;">X</span> |

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# 510(k) Summary for K211942

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## 1. Submitter's Information

- 510(k) Owner's Name: Shenzhen OSTO Technology Company Limited �
- Establishment Registration Number: 3011564440 �
- � Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China
- � Tel: [phone]
- � Fax: [phone]
- Contact Person: Li Yang (General Manger) �
- Email: [e-mail] �

## 2. Application Correspondent:

- Contact Person: Ms. Cassie Lee �
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, � Guangdong, China
- � Tel: [phone]
- Email: [e-mail] �

## 3. Subject Device Information

- Common Name: Powered Muscle Stimulator for Muscle Conditioning, and heating for pain relief, � blood circulation, and muscle performance
- � Trade Name: Heating Lumbar Therapy Cushion (Model: AST-622B, AST-622B, AST-623B)
- Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter �
- � Review Panel: Physical Medicine
- Product Code: NGX, NUH, IRT �
- � Regulation Number: 890.5850
- � Regulation Class: II

# 4. Predicate Device Information

## Predicate Device 1 Information

- Common Name: Transcutaneous electrical nerve stimulator for pain relief �
- 510(k) Number: K190783 �
- Sponsor: Shenzhen OSTO Technology Company Limited �
- � Trade Name: Health Expert Electronic Stimulator (model: AST-300L)
- � Classification Name: Stimulator, Nerve, Transcutaneous, Over-the-Counter
- � Review Panel: Neuroloqy, Physical Medicine
- Product Code: NUH, NGX �
- Regulation Number: 882.5890, 890.5850 �
- � Regulation Class: II

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## Predicate Device 2 Information

- Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle � Stimulation (PMS) unit, and heating for pain relief, blood circulation, and muscle performance
- 510(k) Number: K200561 �
- � Sponsor: JKH Health Co., LTD
- � Trade Name: StimPlus Patch
- Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter �
- � Review Panel: Neurology
- � Product Code: NUH, NGX, NYN, IRT
- Regulation Number: 882.5890 �
- � Regulation Class: II

## 4. Device Description

The Heating Lumbar Therapy Cushion is a portable TENS/PMS device is equipped with a remote control, an adapter, a pair of electrode pads and electrode wire. The electrode wire is used to connect the electrode pads to the main unit.

The device has 5 stimulate modes and one heating mode, through the stainless steel plate to provide users with lower back stimulation and heat generation to warm and comfortable lower back muscles. In addition, it is equipped with a pair of electrode pads, which can be used to stimulate different parts of the body (the shoulder, waist, back, arm and leg).

The principle of operation of the subject device is:

PMS: A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. This device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

TENS: The electrodes placed on the skin send small-scale, low-voltage electrical pulses to specific nerves. The purpose is to change the way neurons send signals and prevent pain signals from reaching the brain to relieve pain.

All the functions of the device can only be controlled by the remote control, which should connected to the main unit through a wire. The remote controller has the component of ON/OFF Key, Mode Selection key (left and right), Intensity Modification keys (increase and decrease) and an LCD screen. And the LCD screen can show stimulation mode, stimulation intensity, heating intensity and time remaining of an application mode. The device has 5 stimulation modes, each with 50 stimulation intensity and one heating Mode, heating mode has 3 levels, namely level 1 (37°C), level 2 (40°C), and level 3 (43°C).

The stainless steel plate provides users with lower back stimulation and heat to warm and comfort the muscles of the lower back. The stimulation function and heating function can be used separately or simultaneously. When used with a pair of electrode pads, it must be used simultaneously with the main unit stimulation mode, otherwise the electrode pads will be invalid.

The equipment has four models: AST-622, AST-622B, AST-623B, the four models differ only in appearance. Please refer to the photographs as below:

| Model | Appearance | Model | Appearance |
|-------|------------|-------|------------|
| | | | |

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Image /page/5/Figure/0 description: The image shows four different versions of a product, labeled AST-622, AST-622B, AST-623, and AST-623B. Each version appears to be a contoured pad or support with a distinct design. The AST-622 version has a smooth surface with recessed areas, while the AST-622B version has a similar shape but with circular indentations on the surface. The AST-623 and AST-623B versions have a different recessed design, with the AST-623B version also featuring circular indentations.

## 5. Intended Use / Indications for Use

PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leq due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

## 6. Test Summary

## 6.1 Non-Clinical Tests Performed

Non-Clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:

- Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
- ◆ Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Usability test according to IEC 62366 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

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- � The waveform test has also been conducted to verify the output specifications of the device according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning".
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards

## 6.2 Discussion of Clinical Tests Performed

There were no Clinical Tests.

## 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Heating Lumbar Therapy Cushion (Model: AST-622, AST-623, AST-623B) is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remar<br>k | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------|
| Device Name | Heating Lumbar Therapy<br>Cushion (Model: AST-622,<br>AST-622B, AST-623, AST-<br>623B) | Health Expert Electronic<br>Stimulator<br>Model: AST-300L | PL-029K29, PL-029K30,<br>and PL-029Q | -- | |
| 510(k) Number | K211942 | K190783 | K200561 | -- | |
| Intended Use | PMS(1 ~ 2): It is intended to<br>stimulate healthy muscles in<br>order to improve and<br>facilitate muscle<br>performance.<br>TENS(3 ~ 5): To be used for<br>temporary relief of pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, arm<br>and leg due to strain from<br>exercise or normal<br>household work activities by<br>applying current to stimulate<br>nerve.<br>Heating: The Heating<br>Lumbar Therapy Cushion is<br>intended for temporary relief<br>of minor aches and pains. | PMS (Mode 1~8)<br>It is intended to stimulate<br>healthy muscles in order<br>to improve and facilitate<br>muscle performance.<br>TENS (Mode 9~25)<br>To be used for temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, back of the<br>neck, arm, leg, and foot<br>due to strain from<br>exercise or normal<br>household work activities<br>by applying current to<br>stimulate nerve. | TENS:<br>PL-029K29, PL-029K30,<br>and PL-029Q are used<br>for temporary relief of<br>pain associated with<br>sore and aching muscles<br>in the shoulder, waist,<br>back, arm, and leg, due<br>to strain from exercise or<br>normal household and<br>work activities.<br>PL-029K29, PL-029K30,<br>and PL-029Q are also<br>intended for<br>symptomatic relief and<br>management of chronic,<br>intractable pain and<br>relief of pain associated<br>with arthritis.<br>PMS:<br>PL-029K29, PL-029K30,<br>and PL-029Q are used<br>to stimulate healthy<br>muscles in order to | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| | | | improve and<br>facilitate muscle<br>performance. To be<br>used for the<br>improvement of muscle<br>tone and firmness, and<br>for strengthening<br>muscles in the arms,<br>abdomen, legs, and<br>buttocks. Not intended<br>for use in any therapy or<br>for the treatment of any<br>medical conditions or<br>diseases.<br>PL-029K29, PL-029K30,<br>and PL-029Q are also<br>intended to temporarily<br>increase local blood<br>circulation in the healthy<br>muscles of lower<br>extremities.<br>Heating:<br>PL-029K30 and PL-<br>029Q is intended for<br>temporary relief of minor<br>aches and pains. | | |
| Treatment site | Shoulder, waist, back, arm<br>and leg | Shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot | Arms, abdomen,<br>shoulder, waist, back,<br>and leg | SE | |
| Principle of<br>Operation | PMS: A powered muscle<br>stimulator for muscle<br>conditioning is a device<br>used for other than medical<br>purposes to apply an<br>electrical current to<br>electrodes on a person's<br>skin to temporarily affect the<br>stimulated muscle's<br>contractile properties, force<br>output, and/or fatigue<br>resistance. This device is<br>not intended for use in<br>patients with medical<br>conditions and is intended | PMS: A powered muscle<br>stimulator for muscle<br>conditioning is a device<br>used for other than<br>medical purposes to<br>apply an electrical current<br>to electrodes on a<br>person's skin to<br>temporarily affect the<br>stimulated muscle's<br>contractile properties,<br>force output, and/or<br>fatigue resistance. This<br>device is not intended for<br>use in patients with | PMS: A powered muscle SE<br>stimulator for muscle<br>conditioning is a device<br>used for other than<br>medical purposes to<br>apply an electrical<br>current to electrodes on<br>a person's skin to<br>temporarily affect the<br>stimulated muscle's<br>contractile properties,<br>force output, and/or<br>fatigue resistance. This<br>device is not intended<br>for use in patients with<br>medical conditions and<br>is intended only for | | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remar<br>k | |
| only for muscle conditioning<br>purposes; TENS: The<br>electrodes placed on the<br>skin send small-scale, low-<br>voltage electrical pulses to<br>specific nerves. The<br>purpose is to change the<br>way neurons send signals<br>and prevent pain signals<br>from reaching the brain to<br>relieve pain. | medical conditions and is<br>intended only for muscle<br>conditioning purposes;<br>TENS: The electrodes<br>placed on the skin send<br>small-scale, low-voltage<br>electrical pulses to<br>specific nerves. The<br>purpose is to change the<br>way neurons send<br>signals and prevent pain<br>signals from reaching the<br>brain to relieve pain. | muscle conditioning<br>purposes; TENS: The<br>electrodes placed on the<br>skin send small-scale,<br>low-voltage electrical<br>pulses to specific<br>nerves. The purpose is<br>to change the way<br>neurons send signals<br>and prevent pain signals<br>from reaching the brain<br>to relieve pain. | | | |
| Power Source(s) | Powered by adapter, 100-<br>240VAC, 50-60Hz<br>Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | Adaptor Input:<br>100-240Vac, 50-60Hz,<br>0.1A<br>Output: 5Vdc, 2A<br>Unit Input: 5Vdc, 2A | Rechargeable or<br>nonrechargeable battery | SE | |
| -Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Battery Supply | SE | |
| -Patient<br>Leakage<br>Current | NC | AC: 54.4uA, DC: 0 | AC: 54.5, DC: 0.5 | 2.0μΑ | SE<br>Note 1 |
| | SFC | AC: 13.4uA, DC: 0 | AC: 54.5, DC: 0.5 | <10.0μΑ | SE |
| Number of Output<br>Channels: | 1 | 2 | 1-2 | SE | |
| Number of Output<br>Modes | For stimulation: 5 modes<br>For heating: 1 mode | 25 | PL-029K29: 8<br>PL-029K30: 8<br>PL-029Q: 8 | SE<br>Note 2 | |
| Output Intensity<br>Level | For stimulation: 50 levels<br>For heating: 3 levels | 99 steps | No publicly available | SE<br>Note 1 | |
| Synchronous or<br>Alternating | Synchronous | Synchronous | Synchronous | SE | |
| Method of Channel<br>Isolation | 1 | 2 | 1 | SE | |
| Regulated Current<br>or Regulated<br>Voltage? | Voltage | Voltage Control | Voltage | SE | |
| Software/Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Automatic Overload<br>Trip | No | No | No | SE | |
| Automatic No-Load<br>Trip | No | No | Yes | SE | |
| Automatic Shut Off | Yes | Yes | Yes | SE | |
| User Override<br>Control | Yes | Yes | Yes | SE | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | Yes | SE |
| | Low<br>battery | No | No | Yes | SE |
| | Voltage /<br>current<br>level | Yes | Yes | No | SE |
| Timer Range | | 5-30 min | 25 to 60 min | PL-029K29: 10~60<br>PL-029K30: 10~60<br>PL-029Q: 10~60 | SE |
| Weight | | Unit: 1704.5g<br>Remote Controller: 73g | 2.1Kg (Without<br>accessories) | Not publicly available | SE<br>Note 2 |
| Dimensions(mm) [L<br>x W<br>x D] | | Model AST-622 and AST-<br>622B:<br>456mm×354mm×86.7mm<br>Model AST-623 and AST-<br>623B:<br>448.9mm×347.9mm×69.9m<br>m<br>Stainless steel:<br>For AST-622:<br>224mm×96mm<br>For AST-622B:<br>224mm×96mm<br>For AST-623:<br>212mm×94mm<br>For AST-623B:<br>212mm×94mm | 429.2mm x 401mm x<br>152.8mm<br>Foot Conductive Rubber:<br>254×98mm | PL-029K29: 150x80x12<br>PL-029K30: 80x55x20<br>PL-029Q: 148x81x29 | SE<br>Note 2 |
| Housing Materials<br>and Construction | | Main unit: ABS Plastic,<br>Stainless steel<br>Red Transparent Plastic: | Main unit (Sole Massage<br>Roller, Unit Housing, | Silicone & ABS | SE |
| Elements of<br>Comparison…