(261 days)
Not Found
No
The description details a pneumatically controlled system with an electronic pump and solenoid valves. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on electrical safety, EMC, biocompatibility, and software verification/validation, not AI/ML performance metrics.
Yes
The device is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation, which are therapeutic claims. It also uses simulated kneading and stroking of tissues, which is a therapeutic action.
No
The device is an air compression leg massager intended for therapeutic purposes (temporary relief of muscle aches, increased circulation), not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a control unit, AC adapter, air hose, and air compression boots with chambers and an air pump. While software is mentioned in the performance studies section for verification and validation, the device is fundamentally a hardware-based system with software controlling the pneumatic functions.
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 for the temporary increase in circulation to the treated foot/calf and thigh." This is a physical therapy/massage application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical device that uses air compression to simulate massage. It does not involve any reagents, analysis of biological samples (like blood, urine, or tissue), or diagnostic procedures.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, biocompatibility, and software validation – all relevant to a physical medical device, but not to an IVD.
In summary, the Air Compression Leg Massager is a therapeutic device that applies physical pressure to the body, not a diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.
Product codes
IRP
Device Description
The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health.
The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following:
- . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots
- . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power.
The subject device is comprised of the following components:
- Control Unit
- AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for converting line power to DC power
- Connector Air Hose (connects Control Unit to the inflatable air compression boots)
- Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, Calf, Thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following standards in connection with medical device electrical safety, electromagnetic compatibility, biocompatibility, and software verification and validation:
(a) ANSI/AAMI ES60601-1 Medical Electrical Equipment-Part1: General Requirements for safety, 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
(b) IEC 60601-1-2, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests, 2014.
(c) IEC 60601-1-11, Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements formedical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0 2015-01.
(d) ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
(e) ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.
(f) Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.
Clinical performance is not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 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 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 3, 2022
Xiamen Healthpal Electronic Co.,Ltd Henry Zhang Manager No.170 Siming Park Tongan District, Xiamen City, Fujian Province, China Xiamen, Fujian 361100 China
Re: K211850
Trade/Device Name: Air Compression Leg Massager (model: FE-7204B) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 26, 2022 Received: February 2, 2022
Dear Henry Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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,
for 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) K211850
Device Name
Air Compression Leg Massager (model: FE-7204B)
Indications for Use (Describe)
Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
The assigned 510(k) number is: K211850 Prepared date: January 25, 2022
Submitter Identification:
Name: Xiamen Healthpal Electronic Co., Ltd. Address: No.170 Siming Park Tongan District, Xiamen City, Fujian Province. China Xiamen, Fujian 361100
Contact Person: Henry Zhang Phone: +86-571-81957767 Fax: +86-571-81957750 Email: zyhenry@163.com
Name of the Device:
Trade Name: Air Compression Leg Massager (model: FE-7204B) Classification Name: Powered Inflatable tube massager
Classification Information:
Regulation Number: 21 CFR 890.5650 Product Code: IRP Device Class: II Review Panel: Physical Medicine
Predicate Device Information:
Sponsor Name: Rapid Reboot Recovery Products. LLC 1396 W 200 S Bldg 2A, Lindon, UT 84042, USA Trade/Device Name: Rapid Reboot Compression Therapy System 510(k) Number: K182668
Device Description:
The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health.
The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following:
- . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots
- . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power.
The subject device is comprised of the following components:
4
- Control Unit
- · AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for
- converting line power to DC power
- · Connector Air Hose (connects Control Unit to the inflatable air compression boots)
- Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.
Characteristics of Air Compression Leg Massager (Model: FE-7204B)
| No | Characteristics |
|---|---|
| 1 | Powered by AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) |
| 2 | Power consumption: 24 W |
| 3 | Size of the control unit (±0.5cm) (Length 20cm ×Height 5.0cm× Width5.5cm) |
| 4 | Massage intensity (weak-medium-strong) |
| Foot: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPa | |
| Calf: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPa | |
| Thigh: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPa | |
| 5 | LCD backlight |
| 6 | LCD size (viewing area ±0.2cm)(2.0cm×3.5cm) |
| 7 | Size of Inflatable boots(Size: ±2cm) |
- Size: 71.5cm ×25cm
- The boots are suitable for the users with the following:
● Foot width : about 12 cm to about 16 cm.
● Calf diameter: about 16.5 cm to about 24cm.
● Thigh diameter: about 19 cm to about 33cm. |
| 8 | Picture of the boots
Image: Picture of the boots |
| 9 | A pair of boots are exclusively for single person use only.
Boots material: Nylon with a polyurethane laminate, and Velcro made of nylon
Air bladder/chamber: TPU (Thermoplastic polyurethanes)
Plastic components: |
| 2. | Lens: PMMA (polymethyl methacrylate) |
| 3. | Air hose: PVC (polyvinyl chloride) |
5
Intended Use/Indication for use :
Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.
Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following standards in connection with medical device electrical safety, electromagnetic compatibility, biocompatibility, and software verification and validation:
(a) ANSI/AAMI ES60601-1 Medical Electrical Equipment-Part1: General Requirements for safety, 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
(b) IEC 60601-1-2, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests, 2014.
(c) IEC 60601-1-11, Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements formedical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0 2015-01.
(d) ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
(e) ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.
(f) Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.
Technological comparison with the predicate device:
Compared with the predicate device, the subject device is similar in design principle, intended use, indications for use, functions, and material, and have been tested to applicable standards. The differences between subject device and predicate device do not raise new questions of safety or effectiveness. See comparison below:
| Elements of
| comparison | Subject device K211850 ) | Predicate Device (K182668) | Conclusion |
|---|---|---|---|
| Manufacturer | Xiamen Healthpal Electronic Co., Ltd. | Rapid Reboot Recovery Products, | |
| LLC | -- | ||
| Product model | FE-7204B | Rapid Reboot Compression Therapy | |
| System | -- | ||
| Regulation name | Powered Inflatable Tube Massager | Powered Inflatable Tube Massager | Identical |
6
Xiamen Healthpal Electronic Co.,Ltd.
| Regulation class | II | II | Identical |
|---|---|---|---|
| Regulation | |||
| number | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| OTC or Rx | OTC | OTC | Identical |
| Indications for | |||
| use | Air compression leg massager, | ||
| model:FE-7204B, is intended for the | |||
| temporary relief of minor muscle aches | |||
| and pains and for the temporary | |||
| increase in circulation to the treated | |||
| foot/calf and thigh in people who are in | |||
| good health. The air compression legstroking of tissues by using air- | |||
| inflatable boots. | The Rapid Reboot Compression | ||
| Therapy System 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. The Rapid Reboot | |||
| Compression Therapy System | |||
| simulates kneading and stroking of | |||
| tissues by using an inflatable | |||
| garment. | Similar Note | ||
| 1 | |||
| Intended use | |||
| environment | Clinics, hospital, athlete training, and | ||
| home environments | Clinics, hospital, athlete training, | ||
| and home environments | Identical | ||
| Treatment area | Leg (including Foot, calf and thigh) | Leg (including Foot, calf and | |
| thigh), Hip, arm | Similar Note | ||
| 2 | |||
| Therapy time | 20 minutes | User determines therapy time. | |
| Choose from 10, 20, or 30 minute | |||
| session time, with option to add | |||
| additional 10 minutes to any | |||
| therapy time. | Different | ||
| Note 3 | |||
| The subject device consists of an air | |||
| pump, two solenoid valves, and air | |||
| compression boots working together | |||
| as one unit. By inflating and deflating | |||
| the air chambers through the control of | 2 modes: "A" mode inflates and | ||
| deflates chambers from bottom up | |||
| (distal to proximal chambers), one | |||
| at a time. "B" mode also inflates | |||
| chambers from bottom up, but | |||
| Modes (visual | |||
| description) | working and/or not working air pump | ||
| and solenoid valves at a regular pace | |||
| and different timing, the components | |||
| simulate kneading and stroking of the | |||
| foot, calf and thigh. There are 3 modes | |||
| for the subject device. |
Mode 1: Pressing
Image: [pressing mode]
Massage the foot, calf and thigh,
Mode 2: kneading
Image: [kneading mode]
Massage the calf-thigh
Mode 3: Shiatsu
Image: [shiatsu mode]
Massage the foot | maintains pressure in lower
chambers as works its way to top.
Then all chambers release pressure at
same time once all chambers have
sequentially inflated.
Mode A:
Image: [mode a]
Mode B:
Image: [mode b] | Different
Note 4 |
| Output pressure
range | 0-33 kPa | 0-200 mmHg | Different
Note 5 |
| Power source | AC100-240V,50/60Hz | 110 V, 60Hz | Different
Note 6 |
| Power
consumption | 24W | 30W | Different
Note 7 |
| Photo/size of the
control unit | Image: [control unit 1]
(Length 20cm ×Height
5.0cm× Width5.5cm ) | Image: [control unit 2]
10" x 6.5" x 5" (in) | Different
Note 8 |
| Weight | About 1.25kg | 5.8 pounds | Different
Note 9 |
| Housing
Materials | Molded ABS enclosure | Molded ABS enclosure | Identical |
| Photo and size of
the boots for leg
(foot, calf and
thigh) |
Size: 71.5cm ×25cm
The feet, calves and thighs which are
suitable for the users with the
following measurements:
● Foot width : about 12 cm to about
16 cm.
● Calf diameter: about 16.5 cm to
about 24 cm.
● Thigh diameter: about 19 cm to
about 33 cm
A pair of boots is for single person
use only. |
X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"
Long: 14" x 48"
X-Long: 14" x 52" | Different
Note 10 |
| Safety Features | Button on display allows user to stop or
pause therapy session at any time. | Button on display allows user to stop
or pause therapy session at any time. | Identical |
| Number of
chambers | 3-chamber | 4-chamber | Different
Note 11 |
| Sleeve materials | Nylon with a Polyurethane laminate | Nylon with a Polyurethane laminate | Identical |
| Mode of
compression | Sequential | Sequential | Identical |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Identical |
| Software/
firmware/
microprocess or
control | Microprocessor | Microprocessor | Identical |
| | FDA-recognized standards | | |
| Electrical safety,
EMC, Bio-
compatibility | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC60601-1-11
ISO 10993-5
ISO 10993-10 | IEC 60601-1
IEC60601-1-2
ISO 10993-5
ISO 10993-10 | Similar
Note 12 |
7
8
Xiamen Healthpal Electronic Co.,Ltd.
Note 1 and Note 2:
The predicate device covers the leg (consisting of foot, calf, knee, upper leg), hip and arm. The subject device covers similar treatment areas including the foot, calf and thigh.
Note 3 and Note 4:
Although the subject device is different than the predicate device in therapy time and massage mode, the subject device has been tested per ANSI/AAMI ES60601-1,IEC
60601-1-2, IEC 60601-1-11, and the software of the subject device has been validated
9
per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, so the difference of therapy and massage modes would not adversely impact safety and effectiveness.
Note 5, Note 6 and Note 7:
Although the subject device is different than the predicate device in output pressure range and power source and power consumption, the subject device has been tested per ANSI/AAMI ES60601-1,IEC 60601-1-2 and IEC 60601-1-11, so the difference would not adversely impact safety and effectiveness.
Note 8 and Note 9:
Although the subject device is different than the predicate device in the weight and the size of control unit, it is believed that the difference in design would not adversely impact safety and effectiveness.
Note 10:
Although the subject device is different than the predicate device in boot size, it is believed that the difference in design would not adversely impact safety and effectiveness.
Note 11:
Although the subject device is different than the predicate device as it pertains to the air chamber, the subject device has been tested per ANSI/AAMI ES60601-1, IEC 60601-1-2 and IEC 60601-1-11, so the difference would not adversely impact safety and effectiveness.
Note 12:
The subject device was tested per the standards noted for the predicate device (ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10), in addition to IEC 60601-1-11.
Summary for clinical test:
Clinical performance is not deemed necessary.
Conclusions:
The Air compression leg massager (model:FE-7204B) has the same indication for use and similar technological characteristics when compared to the predicate device, the Rapid Reboot Compression Therapy System (K182668).Moreover, verification and validation tests contained in this submission demonstrate that the differences between the subject and the predicate devices does not:
10
(1) affect the intended use or (2) alter the safety of the device, and the subject device a is considered substantial equivalent to the predicate device.