(323 days)
The device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Air Pressure Therapy System is a powered inflatable tube massager. The device simulates manual kneading and stroking of tissues by sequential inflated cuffs, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It consists of a main unit, a 4-chamber leg cuff, and an air hose for connecting the unit to the cuff. Only one leg is treated during the treatment process. The cuff inflates and deflates sequentially to apply the pressure on the leg which is controlled by the main unit. Each cuff is equipped with a dedicated air hose. It is to be used by adults.
The FDA 510(k) clearance letter for the Intermittent Pressure Compression System (K242615) does not contain information about a study that proves the device meets specific acceptance criteria in the context of clinical performance (e.g., how effectively it relieves muscle aches or increases circulation). Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (K243320) by meeting recognized safety and performance standards relevant to medical devices of its type.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical characteristics to those of the predicate device and highlights regulatory compliance. The acceptance criteria for clearance are primarily based on demonstrating that the subject device is as safe and effective as the predicate device by meeting recognized safety standards and showing that differences in technical characteristics do not raise new safety or efficacy concerns.
| Feature | Acceptance Criteria (Implied from Predicate or Standards) | Reported Device Performance | Substantial Equivalence Discussion |
|---|---|---|---|
| Indications for Use | "To temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health." (Matching Predicate) | "To temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health." | Same |
| Classification | Class II Device, IRP (21 CFR 890.5650) | Class II Device, IRP (21 CFR 890.5650) | Same |
| Mode of Compression | Sequential (Matching Predicate) | Sequential | Same |
| Max/Min Pressure | Within acceptable therapeutic range, safe operation. Predicate: 30-240 mmHg (Tolerance: ±20mmHg) | 20-200 mmHg (Tolerance: ±20mmHg) | Different - "[L]ower than the predicate device, so there is no safety issue concerned and as for the efficacy, it remains valid since its performance has been demonstrated by the performance testing data included in this submission." |
| Number of Chambers | Sufficient for intended compression (Predicate: 6 chambers) | 4 Chambers | Different - "The 'applicable treatment site' and 'usage instructions' of the subject device fall within the same range as the predicate device, these differences do not impact safety and effectiveness." |
| Therapy Time | Suitable for intended use (Predicate: 5-99 mins) | 0-30 min, selection (10, 20, 30min) | Different - "Shorter treatment time enhances the safety of use." |
| Power Source | Safe and effective (Predicate: Rechargeable Li-ion battery, AC input) | 100-240Vac 50/60Hz (main unit) | Different - "The voltage and current of the power supply are the same. The difference in battery specifications will not affect safety." |
| Safety Feature | Power button allows stop therapy session at any time. | Power button on main unit allows stop therapy session at any time. | Same |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 compliance. | Tested and met the requirements of: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. | Met required safety and essential performance standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "testing was performed and results demonstrated that the Intermittent Pressure Compression System is as safe and effective as the predicate device." However, it does not specify any clinical test set sample size, data provenance, or details of a clinical study to prove efficacy in humans. The testing mentioned refers to compliance with electrical safety and electromagnetic compatibility standards (IEC 60601 series), not clinical trials.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
Not applicable. The clearance is based on substantial equivalence to a predicate device and compliance with device safety standards, not on a clinical ground truth established by experts for performance assessment in humans.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a clinical test set or an adjudication method for human performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is more common for diagnostic imaging devices involving human interpretation. The provided document concerns an intermittent pressure compression system, which is a therapeutic device, and does not mention any MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent in its mechanical and electrical operation, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is primarily established by:
- Substantial Equivalence: Comparison to a legally marketed predicate device (K243320) with known safety and efficacy.
- Compliance with Recognized Standards: Meeting international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). These standards serve as the "ground truth" for basic safety and essential performance.
There is no mention of clinical outcomes data, pathology, or expert consensus specific to the subject device's clinical efficacy in the provided document.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
FDA 510(k) Clearance Letter - Intermittent Pressure Compression System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 23, 2025
Xiamen Taotao Technology Co.,Ltd.
℅ Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China
Re: K242615
Trade/Device Name: Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
Regulation Number: 21 CFR 890.5650
Regulation Name: Powered Inflatable Tube Massager
Regulatory Class: Class II
Product Code: IRP
Dated: June 25, 2025
Received: June 25, 2025
Dear Kiwi Xu:
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"
Page 2
K242615 - Kiwi Xu Page 2
(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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K242615 - Kiwi Xu Page 3
Sincerely,
Tushar Bansal -S
Tushar Bansal, PhD
Acting 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K242615
Device Name
Intermittent pressure compression system (Compression pump, PT1005A; Leg compression cuffs, L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
Indications for Use (Describe)
The device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
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."
Page 5
510(k) Summary
Intermittent Pressure Compression System
K242615
Document prepared date: 2025/07/23
A. Applicant:
Name: Xiamen Taotao Technology Co.,Ltd.
Address: Unit 1309, No. 120, Xinyuan Road, Haicang District, Xiamen City, 361000, Fujian, P.R.China
Contact Person: Chunshui Ma
Tel: +86- 13779930845
Mail: mcsgy@126.com
Submission Correspondent:
Primary contact: Ms. Kiwi Xu
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-17863803443
Email: zxfda@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@gmail.com
B. Subject device:
Trade name: Intermittent Pressure Compression System (Compression Pump, PT1005A; Compression Leg Cuffs, L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
Common name: Powered inflatable Tube Massager
Classification name: Massager, Powered Inflatable Tube
Regulation Medical Specialty: Physical Medicine
Regulation Number: 890.5650
Product Code: IRP
Classification: Class II
C. Predicate device:
K243320
Air Pressure Therapy System (VU-IPC04B)
Xiamen Weiyou Intelligent Technology Co., Ltd.
D. Indications for Use:
Page 6
The device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
E. Device Description:
Air Pressure Therapy System is a powered inflatable tube massager. The device simulates manual kneading and stroking of tissues by sequential inflated cuffs, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It consists of a main unit, a 4-chamber leg cuff, and an air hose for connecting the unit to the cuff. Only one leg is treated during the treatment process. The cuff inflates and deflates sequentially to apply the pressure on the leg which is controlled by the main unit. Each cuff is equipped with a dedicated air hose. It is to be used by adults.
F. Technical Characteristic:
| Product Name & model | Intermittent Pressure Compression System (Compression Pump, PT1005A; Compression Leg Cuffs, L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) |
|---|---|
| Pressure (mmHg) | 20~200 mmHg |
| Mode | 1-6 model |
| Cycle time | 30s |
| Pressure Time | Time 0-30 min, selection (10, 20, 30min) |
G. Substantial Equivalence Table:
| Device | Subject Device (-) | Predicate device（K243320） | SE discussion |
|---|---|---|---|
| Device Name | Intermittent pressure compression system | Air Pressure Therapy System | -- |
| 510(k) ID | K242615 | K243320 | |
| Manufacturer | Xiamen Taotao Technology Co.,Ltd. | Xiamen Weiyou Intelligent Technology Co., Ltd. | |
| Model Name | Compression Pump, PT1005A; Compression Leg Cuffs, L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL | VU-IPC04B | -- |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Indications for Use | The device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas | Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health. | Same |
Page 7
| Device | Subject Device (-) | Predicate device（K243320） | SE discussion |
|---|---|---|---|
| in people who are in good health. | |||
| Rx or OTC | OTC | OTC | Same |
| Environment of use | Clinics, hospital, athlet,training, and home environments. | Clinics, hospital, athlet,training, and home environments. | Same |
| Medical Indications | Relieve muscle pain, relax muscles, increase blood circulation | Relieve muscle pain, relax muscles, increase blood circulation | Same |
| Mode of Compression | Sequential | Sequential | Same |
| Power Source | 100-240Vac 50/60Hz | 10.8 V / 5000mAh Rechargeable Li-ion battery (100-240V AC input 50Hz/60Hz ) | Different - The voltage and current of the power supply are the same. The difference in battery specifications will not affect safety. |
| Therapy Time | 0 – 30 mins | 5-99mins | Different - Shorter treatment time enhances the safety of use. |
| Max Pressure Min Pressure | 20-200mmHg (Tolerance:±20mmHg) | 30-240mmHg (Tolerance:±20mmHg) | Different - The minimum and maximum pressure level of the subject is significantly lower than the predicate device, so there is no safety issue concerned and as for the efficacy, it remains valid since its performance has been demonstrated by the performance testing data included in this submission. |
| Number of Chambers | 4 Chambers | 6 chambers | Different - The "applicable treatment site" and "usage instructions" of the subject device fall within the same range |
Page 8
| Device | Subject Device (-) | Predicate device（K243320） | SE discussion |
|---|---|---|---|
| as the predicate device, these differences do not impact safety and effectiveness. | |||
| Power consumption | 30w | 35w | Different - There is a difference in the power of the heating device between the subject device and the predicate devices. However, while having lower power than equivalent devices is safe. |
| Size | Size 2859090mm | Size 22014090mm | Different - The size and weight differences of the equipment do not affect its safety and effectiveness. |
| Product Weight | 1.6 kg | 1.5 kg | |
| Body area specific cuffs | Leg Cuff: S:90×30cm L:110×30cm XL:110cm×35cm XXL:110cm×40cm XXXL:110cm×50cm | Leg Cuff: M: 91cm×65cm L: 100cm×74cm XL:110cm×70cm(Overlapping) XLP:120cm×70cm(Overlapping) XXL:125cm×74cm(Overlapping) | Different - Size and appearance of cuffs: Slight differences of size and appearance of the sleeves do not raise any safety or efficacy issues. |
Page 9
| Device | Subject Device (-) | Predicate device（K243320） | SE discussion |
|---|---|---|---|
| Work mode | Mode 1: 10 seconds per phaseMode 2: 10 seconds per phaseMode 3: 10 seconds per phaseMode 4: 10 seconds per phaseMode 5: 10 seconds per phaseMode 6: Mode1->Mode2->Mode3->Mode4->Mode5. The above 5 mode cycles take turns | Mode A: In this mode, only a single chamber is inflated at a time. Starting from the chamber ①and working up to the chamber ⑥. Then the cycle repeats.Mode B: In this mode, the chamber ① stays inflated. It gradually adds a chamber until all six chambers are filled with air. Then the cycle repeats.Mode C: In this mode, chamber ① inflates & deflates 4 times, then holds pressure; next chamber ②inflates & deflates 4 times, both chamber ①② hold pressure; Chamber ③ inflates & deflates 4 times, both chamber ②③ hold pressure, chamber ① deflates; chamber ④ inflates & deflates 4 times, both chamber ③④ hold pressure, chamber ② deflates; working as this way up to chamber ⑥ . Then the cycle repeats. Remark: Under this mode, for the first cycle, it works as mode B to pre-run; from the 2nd cycle on, it works as pulse mode C.Mode D: In this mode, all chambers inflates together, and deflates together. Then the cycle repeats. | There is no difference in the way the air pressure drops, and the next cycle begins. Since the treatment area is the same, these differences do not impact safety and effectiveness. |
Page 10
| Device | Subject Device (-) | Predicate device（K243320） | SE discussion |
|---|---|---|---|
| Safety feature | Power button on main unit allows stop therapy session at any time. | Power button on main unit allows stop therapy session at any time. | Same |
| Technology | Compressor and valve system which inflates inflatable chambers sequentially. | Compressor and valve system which inflates inflatable chambers sequentially. | Same |
H. Performance characteristic
The Intermittent Compression System (Compression Pump, PT1005A; Compression Leg Cuffs, L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) has been tested and met the requirements of the following standards:
- IEC 60601‐1 Medical electrical equipment ‐ Part 1: General requirements for basic safety and essential performance
- 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
- IEC 60601-1-11 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
I. Conclusion
This proposed device and the predicated products have similar intend use, device hardware design and device capabilities and performance. To ensure all the key characteristics of the products can meet the requirements, testing was performed and results demonstrated that the Intermittent Pressure Compression System is as safe and effective as the predicate device. Based on the analysis above, we confirm that the subject device is substantially equivalent
Page 11
to the predicate device.
§ 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).