(50 days)
Not Found
No
The description focuses on standard electromechanical components and software control for cold and compression therapy, with no mention of AI, ML, or data-driven decision-making.
Yes
The device is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain, indicating its use in managing and alleviating a medical condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain," and the "Device Description" details its function for "application of external cold therapy and intermittent pneumatic compression therapy." These descriptions clearly indicate a therapeutic purpose rather than a diagnostic one. There is no mention of identifying, measuring, or analyzing medical conditions.
No
The device description clearly outlines multiple hardware components including a cold-compression pad, an insulated container, a lid containing a water pump, electronics, tubing, and a keypad. While it is software-controlled, it is not solely software.
Based on the provided information, the Xrecovery device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Xrecovery is to treat post-surgical and acute injuries by applying cold and compression to the body. This is a therapeutic treatment applied directly to the patient.
- Device Description: The device description details a system for delivering external cold therapy and intermittent pneumatic compression. It involves physical components like pads, a container for ice and water, and pumps.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Xrecovery does not interact with or analyze any bodily specimens.
The Xrecovery is a therapeutic medical device used for physical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Xrecovery is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Product codes
IRP, ILO
Device Description
The Xrecovery is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.
The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The device is intended to be used with Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.
The insulated container is filled with ice and water by the user. The water circulates through the cold- compression pad to deliver cold therapy to the application site.
The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back, shoulder, hip, knee, foot/ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
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
The testing for Xrecovery included use life testing, software, electromagnetic compatibility, biocompatibility and bench testing. Xrecovery passed all testing in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the subject device was conducted in accordance with Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following endpoints were evaluated for the patient-contacting components:
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
Results: The results of these test demonstrated that the patient-contacting components of the subject device are noncytotoxic, non-sensitizing, and non-irritating.
Electrical safety and electromagnetic compatibility: The subject device has been tested in accordance with and found to comply with the following standards:
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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
Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
Performance Testing: The Xrecovery has been subjected to design verification and validation testing. These tests verified and validated the proper operation of the System. The Xrecovery device has been found to be adequately safe and effective for the intended users, its intended uses, and use environment. The labeling materials have been found to be easy to use and understandable to the intended users.
Key Metrics
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 shows the date November 14, 2024. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black and the background is white.
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Shenzhen Xinrun Electric Appliances Co Ltd % Tulin Li Medical Device Consultant Huide Medical Technology Service Group Co., Ltd Room 703, Building 16, South Bank Plaza, Exhibition Bay, Zhancheng Community, Fuhai Street, Bao'an District Shenzhen, Guangdong 518053 China
Re: K242940
Trade/Device Name: Xrecovery (XR-001) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. ILO Dated: September 10, 2024 Received: September 25, 2024
Dear Tulin 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Tushar Bansal -S
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
3
Indications for Use
510(k) Number (if known) K242940
Device Name Xrecovery (XR-001)
Indications for Use (Describe)
The Xrecovery is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
| 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) |
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."
4
510(K) SUMMARY -K242940
1. Submitter of 510(K):
Sponsor:
| Company Name: | SHENZHEN XINRUN ELECTRIC APPLIANCES CO LTD |
|---|---|
| Address: | Shenzhen Boan District, Shajing Street, Wanan Rd, Changxing Technology Park, |
| No13, RM 401, RM | |
| Contact person: | Mr Guo Chong |
| TEL: | +86-755-8177326 |
| E-mail: | 3838444731@qq.com |
Application Correspondent:
| Company Name: | Huide Medical Technology Service Group Co., Ltd |
|---|---|
| Address: | Room 703, Building 16, South Bank Plaza, Exhibition Bay, Zhancheng Community, |
| Fuhai Street,Shenzhen,Guangdong,518053,China | |
| Contact person: | Mr. Tulin Li |
| TEL: | +86-1868029562 |
| E-mail: | amos.zou@139.com |
Date 510(k) Summary Prepared: November 2,2024
2. Proposed Device and code:
| Device Name | Xrecovery |
|---|---|
| Model | XR-001 |
| Common Name | Powered Inflatable Tube Massager |
| Regulation Name | Powered Inflatable Tube Massager |
| Regulation Number | 21 890.5650 |
| Regulatory Class | Class II |
| Product Code | IRP, ILO |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K183702 | Polar Care Wave | Breg Inc. |
5
The predicate device has not been subject to a design-related recall.
4. Device Description:
The Xrecovery is an AC powered, software controlled, multimodality system. The device is intended for application of external cold therapy and intermittent pneumatic compression therapy to be used by, or on the order of, licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings. The device features a multi-setting cold therapy module and multi-setting compression therapy module which can be run simultaneously or independently.
The device contains three key parts: A cold-compression pad with connector, an insulated container to hold ice and water, and a lid that contains a water pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.
The device is intended to be used with Cold-Compression pads only, which are designed for specific application sites. The cold-compression pads are available for the core regions; back, shoulder, hip, and knee and for the extremity region, foot/ankle. The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.
The insulated container is filled with ice and water by the user. The water circulates through the cold- compression pad to deliver cold therapy to the application site.
The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional
న్. Indications for Use
The Xrecovery is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Comparison of Intended Use and Technological Characteristics 6.
The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:
| Feature | Primary Predicate Device | Subject Device | Equivalence |
|---|---|---|---|
| Product Code | |||
| Regulation | |||
| Number | Polar Care Wave (K183702) | ||
| IRP Powered inflatable tube massager | |||
| (21 CFR 820.5650) | |||
| ILO Water circulating hot or cold pack (21 CFR 890.5720) | Xrecovery(K242940) | ||
| IRP Powered inflatable tube massager (21 CFR 820.5650) | |||
| ILO Water circulating hot or cold pack (21 CFR 890.5720) | / | ||
| SE | |||
| Regulatory | |||
| Class | II | II | SE |
| Intended Use | The Polar Care Wave system is | ||
| intended to treat post-surgical and | |||
| acute injuries to help reduce edema, | |||
| swelling, and pain where cold and | |||
| compression are indicated. It is | The Xrecovery is intended to treat post- | ||
| surgical and acute injuries to reduce | |||
| edema, swelling, and pain where cold | |||
| and compression are indicated. It is | SE | ||
| intended to be used by or on the order | |||
| of licensed healthcare professionals in | |||
| hospitals, outpatient clinics, athletic | |||
| training settings, or home settings. | intended to be used by or on the order of | ||
| licensed healthcare professionals in | |||
| hospitals, outpatient clinics, athletic | |||
| training settings, or home settings. | |||
| Indications | |||
| for Use | The Polar Care Wave System is intended | ||
| to treat post-surgical and acute injuries | |||
| to reduce edema, swelling, and pain | |||
| where cold and compression are | |||
| indicated. It is intended to be used by or | |||
| on the order of licensed healthcare | |||
| professionals in hospitals, outpatient | |||
| clinics, athletic training settings, or | |||
| home settings. | The Xrecovery is intended to treat post- | ||
| surgical and acute injuries to reduce | |||
| edema, swelling, and pain where cold | |||
| and compression are indicated. It is | |||
| intended to be used by or on the order of | |||
| licensed healthcare professionals in | |||
| hospitals, outpatient clinics, athletic | |||
| training settings, or home settings. | SE | ||
| Intended | |||
| Users | Health Care Professionals and lay users | ||
| (under prescription). | Health Care Professionals and lay users | ||
| (under prescription). | SE | ||
| Intended Use | |||
| Environment | Intended for indoor use | Intended for indoor use | SE |
| Therapy | Cold and Compression | ||
| Work together or independently | Cold and Compression | ||
| Work together or independently | SE | ||
| Therapy | |||
| sessions | Manual mode – allows the user to | ||
| adjust cold and compression settings as | |||
| directed by a Health Care Professional. | Manual mode – allows the user to adjust | ||
| cold and compression settings as directed | |||
| by a Health Care Professional. | SE | ||
| Types of | |||
| Pads | Various anatomical pads: | ||
| Knee, Shoulder, Back, Hip, Universal, | |||
| Foot/Ankle | Various anatomical pads: | ||
| Knee, Shoulder, Back, Hip, Universal, | |||
| Foot/Ankle | SE | ||
| Compression | |||
| Setting | Available in two levels Low (0-25 mm | ||
| Hg) | |||
| Regular (0-50 mm Hg) | Available in two levels Low (0-25 mm | ||
| Hg) | |||
| Regular (0-52 mm Hg) | SE | ||
| Cold | |||
| Therapy | Available without and with | ||
| compression (Low and Regular) | Available without and with compression | ||
| (Low and Regular) | SE | ||
| Therapy | |||
| Temperature | |||
| Range | 45°F-60°F | 45°F-60°F | SE |
| Heat | |||
| Therapy | Not Available | Not Available | SE |
| User | |||
| Interface | Keypad with indicator lights | Keypad with indicator lights | SE |
| Operating | |||
| Fluid | Tap Water | Tap Water | SE |
| Water | |||
| Cooling | |||
| Source | Ice | Ice | SE |
| Single User | |||
| Cold | |||
| Compression | |||
| Pad | Yes | Yes | SE |
| Cold | |||
| Compression | |||
| Pad Sterility | Non-Sterile | Non-Sterile | SE |
| Line Voltage | |||
| / Frequency | 100-240 VAC | ||
| 50/60 HZ | 100-240 VAC | ||
| 50/60 HZ | SE |
6
Substantial Equivalence
7
None of the performance or technological differences between the predicates raise any new issues of safety and effectiveness.
7. Non-Clinical PERFORMANCE DATA
The testing for Xrecovery included use life testing, software, electromagnetic compatibility, biocompatibility and bench testing. Xrecovery passed all testing in support of the substantial equivalence determination:
7.1. Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"." As dictated by the nature of body contact (intact skin) and contact duration (less than 24 hours), the following endpoints were evaluated for the patient-contacting components:
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
-
ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
The results of these test demonstrated that the patient-contacting components of the subject device are noncytotoxic, non-sensitizing, and non-irritating.
Electrical safety and electromagnetic compatibility 7.2.
The subject device has been tested in accordance with and found to comply with the following standards:
-
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 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
Software Verification and Validation Testing 7.3.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
7.4. Performance Testing
The Xrecovery has been subjected to design verification and validation testing. These
tests verified and validated the proper operation of the System. The Xrecovery device has been
found to be adequately safe and effective for the intended users, its intended uses, and use environment. The labeling materials have been found to be easy to use and understandable to the intended users.
8. Conclusions:
The results of the testing described above demonstrate that the Xrecovery is as safe and effective as the predicate device and supports a determination of substantial equivalence.