(173 days)
Not Found
No
The device description and performance studies focus on standard electrical stimulation and heating functionalities, with no mention of AI or ML algorithms for data analysis, personalized therapy, or adaptive control. The control is described as being solely through a remote with fixed modes and intensity levels.
Yes
The device is intended for pain relief and muscle conditioning, which are therapeutic uses.
No
Explanation: The device is intended to stimulate muscles for performance improvement and pain relief, and also provides heating for minor aches and pains. It does not state that it analyzes or interprets any physiological data to diagnose a condition.
No
The device description explicitly mentions hardware components such as a main unit, remote control, adapter, electrode pads, electrode wire, and a stainless steel plate. It also describes physical functions like electrical stimulation and heating. While software is mentioned for verification and validation, the device is clearly a combination of hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a TENS/PMS device with a heating function. It applies electrical stimulation and heat directly to the body's surface. It does not analyze any biological samples.
- Intended Use: The intended uses are for muscle stimulation, pain relief, and temporary relief of minor aches and pains. These are all therapeutic or symptomatic relief purposes, not diagnostic ones.
Therefore, the Heating Lumbar Therapy Cushion falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NGX, NUH, IRT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, arm and leg (for TENS and PMS); Lower back (for heating)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
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"
- 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.
There were no Clinical Tests.
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
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) X |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: +86-755-29769546
- � Fax: +86-755-29769540
- Contact Person: Li Yang (General Manger) �
- Email: annaosto@163.com �
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: +86 20 8266 2446
- Email: regulatory@glomed-info.com �
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
4
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 |
|---|---|---|---|
5
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"
6
- � 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
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remar
k | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------|
| Device Name | Heating Lumbar Therapy
Cushion (Model: AST-622,
AST-622B, AST-623, AST-
623B) | Health Expert Electronic
Stimulator
Model: AST-300L | PL-029K29, PL-029K30,
and PL-029Q | -- | |
| 510(k) Number | K211942 | K190783 | K200561 | -- | |
| 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. | PMS (Mode 18)25)
It is intended to stimulate
healthy muscles in order
to improve and facilitate
muscle performance.
TENS (Mode 9
To be used for temporary
relief of pain associated
with sore and aching
muscles in the shoulder,
waist, back, back of the
neck, arm, leg, and foot
due to strain from
exercise or normal
household work activities
by applying current to
stimulate nerve. | TENS:
PL-029K29, PL-029K30,
and PL-029Q are 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 and
work activities.
PL-029K29, PL-029K30,
and PL-029Q are also
intended for
symptomatic relief and
management of chronic,
intractable pain and
relief of pain associated
with arthritis.
PMS:
PL-029K29, PL-029K30,
and PL-029Q are used
to stimulate healthy
muscles in order to | SE | |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| | | | improve and
facilitate muscle
performance. To be
used for the
improvement of muscle
tone and firmness, and
for strengthening
muscles in the arms,
abdomen, legs, and
buttocks. Not intended
for use in any therapy or
for the treatment of any
medical conditions or
diseases.
PL-029K29, PL-029K30,
and PL-029Q are also
intended to temporarily
increase local blood
circulation in the healthy
muscles of lower
extremities.
Heating:
PL-029K30 and PL-
029Q is intended for
temporary relief of minor
aches and pains. | | |
| Treatment site | Shoulder, waist, back, arm
and leg | Shoulder, waist, back,
back of the neck, arm,
leg, and foot | Arms, abdomen,
shoulder, waist, back,
and leg | SE | |
| Principle of
Operation | 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 | 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 | PMS: A powered muscle SE
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 | | |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remar
k | |
| 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. | 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. | 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. | | | |
| Power Source(s) | Powered by adapter, 100-
240VAC, 50-60Hz
Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | Adaptor Input:
100-240Vac, 50-60Hz,
0.1A
Output: 5Vdc, 2A
Unit Input: 5Vdc, 2A | Rechargeable or
nonrechargeable battery | SE | |
| -Method of Line
Current Isolation | Type BF Applied Part | Type BF Applied Part | Battery Supply | SE | |
| -Patient
Leakage
Current | NC | AC: 54.4uA, DC: 0 | AC: 54.5, DC: 0.5 | 2.0μΑ | SE
Note 1 |
| | SFC | AC: 13.4uA, DC: 0 | AC: 54.5, DC: 0.5 |