(117 days)
No
The description focuses on a simple pneumatic system with sequential inflation/deflation controlled by a basic controller, and there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas, which are therapeutic claims.
No
The device is intended for "temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas," and simulates "kneading and stroking of tissues." These are therapeutic functions, not diagnostic ones. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is comprised of hardware components including an air compressor, controller, sleeves, hose, and power supply (external or internal battery). While it contains software, it is not solely software.
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 "temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical therapy device that applies pressure to the body. It does not involve analyzing samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro diagnostics, such as reagents, assays, sample collection, or laboratory analysis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely physical therapy.
N/A
Intended Use / Indications for Use
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves.
The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit.
The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health.
The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg and Foot
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical testing:
The Leg and Foot Air Wave Pressure Therapy Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- -ANSI/AAMI ES60601-1: 2005+A1:2012; AMD2:2021, Medical Electrical Equipment - Part 1: General Requirements for Safety,
- -IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- -IEC 60601-1-11 Edition 2.0 2015-01, 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 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
- -The software was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The device also was verified with the following benching testing and usability study:
- Product service life verification -
- -Burst Strength Test
- Product performance testing after reliability testing -
Tests results are supporting all labeling claims in order to establish substantial equivalency.
Usability Study was completed in the subject device:
A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/self-selection and usability/user interface studies.
Clinical testing: Clinical testing is not necessary for the subject device.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
March 14, 2023
Zhangzhou Easepal Innovation Co Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou City, China Guangzhou, Guangdong 510000 China
Re: K223464
Trade/Device Name: Leg and Foot Air Wave Pressure Therapy Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 3, 2023 Received: March 3, 2023
Dear Jet Li:
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.
1
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 L. Dean -S
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) K223464
Device Name
Leg and Foot Air Wave Pressure Therapy Device
Indications for Use (Describe)
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate kneading and stroking of tissues by using an inflatable garment.
| 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)
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 K223464.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements according to 21 CFR 807.92 (c), and there were no prior submissions for the subject device.
1. Submitter Information
Sponsor: ZHANGZHOU EASEPALINNOVATION CO., LTD.
Address: No.36 Longkun Road, Hongjian Village, Jiaomei Town, Zhangzhou Taiwanese Investment
Zone, Fujian CHINA 363000
Contact Person: Xu Zibing
Title: Quality Manager
Phone: 13275000278
E-mail: eqc-oca@easepal.com.cn
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China
2. Subject Device Information
Type of 510(k) submission: Traditional Common Name: Leg and Foot Air Wave Pressure Therapy Device Model: EP-1129 Classification Name: Powered inflatable tube massager Review Panel: Physical Medicine Product Code: IRP
4
Regulation Number: 21 CFR 890.5650
Regulation Class: 2
| Item | Predicate Device | Reference Device |
|---|---|---|
| Sponsor | Shenzhen Dongjilian Electronics | |
| Co., Ltd. | Ceragem International, Inc. | |
| Device Name | Air Compression Therapy | |
| Device | Ceragem Automatic Thermal | |
| Massager, Model CGM MB-1701 & | ||
| CGM MB-1702 | ||
| 510(k) Number | K193354 | K220572 |
| Product Code | IRP | IRP |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5880, |
| 21 CFR 890.5650 | ||
| Regulation Class | 2 | 2 |
3. Predicate and Reference Device Information
4. Device Description
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves.
The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit.
The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health.
The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.
5. Intended Use/Indication for use
Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good heath, it can simulate kneading and stroking of tissues by using an inflatable garment.
6. TestSummary
5
Non Clinical testing:
The Leg and Foot Air Wave Pressure Therapy Device has been evaluated the safety and performance by lab bench testing according to the following standards:
- -ANSI/AAMI ES60601-1: 2005+A1:2012; AMD2:2021, Medical Electrical Equipment - Part 1: General Requirements for Safety,
- -IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- -IEC 60601-1-11 Edition 2.0 2015-01, 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 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
- -The software was validated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The device also was verified with the following benching testing and usability study:
- Product service life verification -
- -Burst Strength Test
- Product performance testing after reliability testing -
Tests results are supporting all labeling claims in order to establish substantial equivalency.
Usability Study was completed in the subject device:
A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/self-selection and usability/user interface studies.
Clinical testing: Clinical testing is not necessary for the subject device.
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness. See the below form.
6
| Elements of
| comparison | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Manufacturer | ZHANGZHOU EASEPAL | ||
| INNOVATION CO., LTD. | Shenzhen Dongjilian Electronics Co., Ltd. | Ceragem International, Inc. | |
| 510K number | K223464 | K193354 | K220572 |
| Product Name | Leg and Foot Air Wave Pressure | ||
| Therapy Device | |||
| Model EP-1129 | Air Compression Therapy Device (S9019) | Ceragem Automatic Thermal Massager, Model | |
| CGM MB-1701 & CGM MB-1702 | |||
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5880, |
| 21 CFR 890.5650 | |||
| Classification Name | Powered inflatable tube massager | Powered inflatable tube massager | Powered inflatable tube massager |
| Regulation Class | 2 | 2 | 2 |
| OTC & Rx | OTC | OTC | OTC |
| Indications for Use | Leg and Foot Air Wave Pressure | ||
| Therapy Device EP-1129 is | |||
| intended for the temporary relief of | |||
| minor muscle aches and pains and | |||
| for the temporary increase in | |||
| circulation to the treated areas in | |||
| people who are in good health, it | |||
| can simulate kneading and | |||
| stroking of tissues by using an | |||
| inflatable garment. | The Air Compression Therapy Device is | ||
| indicated for the temporary relief of minor | |||
| muscle aches and pains and for | |||
| temporary increase in circulation to the | |||
| treated areas in people who are in good | |||
| health. The Air Compression Therapy | |||
| Device simulates kneading and stroking of | |||
| tissues by using an inflatable garment. | The intended use of the Ceragem Automatic | ||
| Thermal Massager, Model CGM MB-1701 & CGM | |||
| MB-1702 is to provide muscle relaxation therapy by | |||
| delivering heat and soothing massage. | |||
| Additionally, the product provides topical radiant | |||
| infrared heat for: | |||
| -Temporary relief of minor muscle and joint pain | |||
| stiffness | |||
| -Temporary relief of minor joint pain associated with | |||
| arthritis | |||
| -Temporary increase in local circulation where | |||
| applied |
- Relaxation of muscles
The Air Cell Massager (only CGM MB-1701) is
indicated for the temporary relief of minor muscle
aches and pains and for temporary increase in |
| Elements of
comparison | Subject Device | Predicate Device | Reference Device |
| Power Source | AC100-240V, 50/60Hz | 100240V 50/60Hz | 100-127Vac 50/60Hz |240 mmHg |
| Power consumption | 11.1W | 12W | 480VA |
| Dimensions (WHD) | 340210850mm | 10.25.925.6 (in) | / |
| Photo | Image: Subject Device Remote | Image: Predicate Device Remote | / |
| Weight | 2.0 Kg(4.4pounds) | 4.6 pounds | / |
| Size and appearance
of sleeves (leg part) | Image: Subject Device Leg Sleeves
One size: 8534 cm | Image: Predicate Device Leg Sleeves
One size: 7326 cm | Image: Reference Device Leg Sleeve
Leg:
One size: 28*58.4cm |
| Inflation time | 20-50 s | 3-30 s | 1 min ~ 1 min 30 s |
| Keep time | 1-3 s | 1-5 s | 1 ~ 13 s |
| Elements of
comparison | Subject Device | Predicate Device | Reference Device |
| Deflation time | 5 s | 1-5 s | 1 ~ 10 s |
| Cycle time | 30 seconds to 3 mins | Range of 25 sec to 3 min 40 sec | Range of 28 sec to 39 sec |
| Number of Chambers | 3 Chambers | 3 Chambers | 4 Chambers |
| Sleeve Materials | Tribute satin and Oxford cloth | Nylon with a Polyurethane laminate | Oxford and Nylon |
| Mode of Compression | Sequential | Sequential | Sequential |
| Device Pressure range | 90-225mmHg | 0-240 mmHg | 48
| Air pressure level
/Compression levels | 4 levels settings:
Level 1:90mmHg;
Level 2:135mmHg;
Level 3: 188mmHg
Level 4: 225mmHg | 3 levels settings:
low level:150mmHg;
Mid level:185mmHg;
High Level: 215mmHg | 9 levels settings:
Level 1 : 48mmHg
Level 2 : 72mmHg
Level 3 : 96mmHg
Level 4 : 120mmHg
Level 5 : 144mmHg
Level 6 : 168mmHg
Level 7 : 192mmHg
Level 8 : 216mmHg
Level 9 : 240mmHg |
| Treatment Time | Default as 15min | 20 min | 18 minutes |
| Work Mode | Image: Compression Mode | Mode 1:
Starting with the foot chamber and
progressing up the thigh chamber, each | Image: Diagram of foot and leg |
| Elements of
comparison | Subject Device | Predicate Device | Reference Device |
| | Image: Subject Device | | |
| | M1: ① → ② → ③ (sole air bags
inflate - deflate - calf air bag
inflates - deflate - thigh air
bags inflate - deflate - cycle in
turn)
M2: ① → ①② → ①②③ (Sole
air bags inflate - pressure
maintaining-- calf air bag inflate
--pressure maintaining- thigh air
bags inflate - sole, calf, thigh air
bags deflate simultaneously --
cycle in turn)
M3: ① → ② → ③ → ① → ①②
→ ①②③ (Sole air bags inflate
deflate - calf air bag inflates -
deflate - thigh air bags inflate -
deflate - sole air bags inflate -
pressure maintaining - calf air
bag inflates - pressure
maintaining - thigh air bags
inflate- sole, calf, thigh air bags
deflate simultaneously- cycle in
turn)
Cycle in turn. | section compresses and the
pressure gradually rises to the pre-
determined air pressure level, then
decompresses and the air pressure drops.
Once the thigh section decompresses, the
cycle begins again.
Mode 1 follows this pressure sequence:
Image: Predicate Device Mode 1
Mode 2:
Starting with the foot chamber and
progressing up the thigh, each section
compresses and the pressure gradually
rises to the pre-determined air pressure
level, holds the air until the entire garment
is compressed. All three sections then
decompress simultaneously and the air
pressure drops, then cycle begins again.
Mode 2 follows this pressure sequence:
Image: Predicate Device Mode 2 | Mode 1:
Starting with the foot chamber and progressing up
the thigh chamber, each section compresses and
the pressure gradually rises to the pre-determined
air pressure level, then decompresses and the air
pressure drops. Once the thigh section
decompresses, the cycle begins again.
Mode 2:
Starting with the foot chamber and progressing up
the thigh, each section compresses, and the
pressure gradually rises to the pre-determined air
pressure level, holds the air until the entire garment
is compressed. All four sections then decompress
simultaneously, and the air pressure drops, then
cycle begins again.
Mode 3:
Start between the foot chamber to the thigh
chamber except for No. 4 chamber. And No.4
chamber is compressed while the other chambers
are maintained. After that all four sections
decompress simultaneously and the air pressure
drops, then cycle begins again. This sequence is
similar to the Mode 2. |
| Elements of
comparison | Subject Device | Predicate Device | Reference Device |
| | | Mode 3:
include two stage, stage 1: it works
according to the method of mode 1, after
the stage 1 is completed, it goes to stage
2(working according to the method of mode
- without interruption time until finish the
stage 2, then enter next cycle without
interruption.
Mode1 $\rightleftharpoons$ Mode2
The pressure sequence of mode 3
combines mode 1 and mode 2 | |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Non-conductive attachments |
| Software/Firmware/Mic
roprocessor Control | Microprocessor | Microprocessor | Microprocessor |
| Technology | Compressor and valve system
which sequentially inflates cells of
appliance | Compressor and valve system which
sequentially inflates cells of appliance | Compressor and valve system which sequentially
inflates cells of appliance |
| Electrical safety, EMC | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 62133 | ES 60601-1;
IEC 60601-1-2;
ISO 10993-5;
ISO 10993-10;
IEC 60601-1-11 | ANSI AAMI ES60601-1:2005
IEC 60601-1-2 Edition 4.0
IEC 60601-1-6 Edition 3.1
IEC 60601-1-11 Edition 2.0
ISO 10993-5 Third edition
ISO 10993-10 Third Edition |
7
8
9
10
11
8. Conclusion
The subject device Leg and Foot Air Wave Pressure Therapy Device has all features of the predicate devices for intended use. Thus, the subject device is substantially equivalent to the predicate devices.
9. Summary Prepared Date
3 March 2023