Cryopush Cold Compression Device (A02-P-001)
Device Facts
| Record ID | K253076 |
|---|---|
| Device Name | Cryopush Cold Compression Device (A02-P-001) |
| Applicant | Chengdu Cryo-Push Medical Technology Co.,Ltd |
| Product Code | IRP · Physical Medicine |
| Decision Date | Apr 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Device Story
Device consists of main control unit and inflatable wraps; provides pneumatic compression and cold therapy. User selects pressure (20-100 mmHg); unit inflates wrap, holds for 10 seconds, then releases; cycle repeats. Default operation 30 minutes. Powered by rechargeable lithium batteries; portable. Used in clinics, hospitals, athlete training, and home environments by patients or clinicians. Output is mechanical compression and localized cooling; intended to relieve minor muscle aches and pains and increase circulation. Cold pack provides localized cold therapy. Device is non-invasive; patient-operated.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2), battery safety (IEC 62133-2), electromagnetic immunity (AIM 7351731, IEEE ANSI C63.18), and internal performance testing (appearance, wrap function, service life, environmental stress, and pressure accuracy).
Technological Characteristics
Powered inflatable tube massager; 100-240V AC or rechargeable lithium battery. Wraps made of nylon with PVC laminate. Pressure range 0-100 mmHg; 10s hold time, 20s deflation. Operating temperature 5°C-40°C; cold pack operating range -18°C to +2°C. Software-controlled pneumatic system.
Indications for Use
Indicated for healthy individuals requiring temporary relief of minor muscle aches and pains, temporary increase in local circulation, and localized cold therapy.
Regulatory Classification
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.
Predicate Devices
- Air Compression Therapy Recovery System (K222669)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 2, 2026
Chengdu Cryo-push Medical Technology Co., Ltd
% Aria Yao
Regulatory Affairs Specialist
Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square
Liuxian Avenue, Xili Town, Nanshan District
Shenzhen, Guangdong 518000
China
Re: K253076
Trade/Device Name: Cryopush Cold Compression Device (A02-P-001)
Regulation Number: 21 CFR 890.5650
Regulation Name: Powered Inflatable Tube Massager
Regulatory Class: Class II
Product Codes: IRP, IME
Dated: June 18, 2025
Received: September 23, 2025
Dear Aria Yao:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253076 - Aria Yao
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-
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K253076 - Aria Yao
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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).
Sincerely,
DIGITALLY SIGNED BY
ZACHARY MCKINNEY -S
Date: 2026.04.02
15:38:44 -04'00'
for 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
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253076 | |
| Device Name Cryopush Cold Compression Device (A02-P-001) | |
| Indications for Use (Describe) The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. | |
| 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." | |
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Chengdu Cryo-Push Medical Technology Co., Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
# 510(k) Summary K253076
## 1. Contact Details
### 1.1 Applicant information
| Applicant Name | Chengdu Cryo-Push Medical Technology Co., Ltd |
| --- | --- |
| Address | 102, 105, Zone 20, Huayin Industrial Port, No.618, Kexing Road (West), Wenjiang District, Chengdu 611137 Sichuan P.R.China |
| Phone No. | TEL: +86 18086852687 |
| Contact person | Zhang Peiyong |
| Date Prepared | Aug.10.2022 |
### 1.2 Submission Correspondent
| | Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square,
Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,
Guangdong Province, China
+86 755-86069197 |
| --- | --- |
| Phone No. | |
| Contact person | Aria Yao |
| Contact person's e-mail | aria@cefda.com; james_tsai@cefda.com |
| Website | http://www.cefda.com |
## 2. Device information
| Trade name | Cryopush Cold Compression Device (A02-P-001) |
| --- | --- |
| Classification | Ⅱ |
| Classification name | Massager, Powered Inflatable Tube |
| Product code | IRP |
| | IME |
| Regulation No. | 21 CFR 890.5650 |
## 3. Legally Marketed Predicate Device
| Trade Name | Air Compression Therapy Recovery System |
| --- | --- |
| 510(k) Number | K222669 |
| Product Code | IRP, IME |
| Manufacturer | Cryo-Push Medical Technology Co., Ltd |
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Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
## 4. Device Description
The Cryopush Cold Compression Device consists of a main unit and wraps. Main unit inflates the wrap to a specified pressure of 20 mmHg, 40 mmHg, 60 mmHg, 80 mmHg or 100 mmHg (set by the user), and once the pressure reached the targeted level, it will hold for 10 seconds before releasing, then decompresses and the air pressure drops. The cycle begins again. Default working time is 30 minutes. Built-in rechargeable lithium batteries allow the system to be completely portable for use anytime and anywhere. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. When the A02-P-001 is used for a default time of 30 minutes at the operating temperature (5°C~40°C) specified in the user manual, the operating temperature of the cold pack is (-18°C~+2°C) (±2°C).
## 5. Intended use
The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
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Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
# 6. Substantial Equivalence Comparison
| Item | Proposed Device: | Predicate Device (K222669) | | Comments |
| --- | --- | --- | --- | --- |
| Regulation number | 890.5650 | 890.5650 | | Same |
| Classification | II | II | | Same |
| Model | A02-P-001 | A02-P-001 | A02-P-002 | Same |
| Product Code | IRP, IME | IRP, IME | | Same |
| Intended use/Indications for use | The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. | The Cryopush Cold Compression Device is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable. | The Cryopush A02-P-002 is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using by an inflatable wrap. | |
| Treatment area/Structure of Sleeves | Leg (Ankle, Calf and upper leg), Hip, Arm (Hand/wrist, Shoulder, Elbow), Back (Neck, Back, Lower Back) | Low limbs (Calf and upper leg) | | Note 1 |
| OTC or Rx | OTC | OTC | | Same |
| Environment of Use | Clinics, hospital, athlete training, and home environments | Clinics, hospital, athlete training, and home environments | | Same |
| Power source | 100-240V~50/60Hz | 100-240V~50/60Hz | | Same |
| Working Time | 10min, 20 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, 110 min, 120 min, | 10min, 20 min, 30 min, 40 min, 50 min, 60 min, 70 min, 80 min, 90 min, 100 min, | 10min, 20 min, 30 min, 40 min, 50 min, 60 min, default as 30min | Same |
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Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
| Item | Proposed Device: | Predicate Device (K222669) | | Comments |
| --- | --- | --- | --- | --- |
| | default as 30min | 110 min, 120 min, default as 30min | | |
| Pressure range | 0-100mmHg | 0-100mmHg | 0~215 mmHg | Same |
| Pressure levels | 20mmHg,40 mmHg,60 mmHg,80 mmHg,100 mmHg. | 20mmHg,40 mmHg,60 mmHg,80 mmHg,100 mmHg. | 100mmHg,160 mmHg,215mmHg; | |
| Pressure error range | ±15mmHg | ±15mmHg | ±20mmHg | |
| Keep time | 10s | 10s | | Same |
| Deflation time | 20s | 20s | | |
| Working process | The pressure of the chamber gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. The cycle begins again. | The pressure of the chamber gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. The cycle begins again. | Starting with the lower chamber and progressing up the upper chamber, each section compresses and the pressure gradually rise to the pre-determined air pressure level, then decompresses and the air pressure drops. Once the upper chamber decompresses, the cycle begins again. | Same |
| Noise level | ≤ 55dB | ≤ 55dB | | Same |
| Wrap Material | Nylon with a PVC laminate | Nylon with a PVC laminate | | Same |
| Patient contact | Non-conductive attachments | Non-conductive attachments | | Same |
| Appearance | | | | Note 2 |
| Wrap Size | A02-C-020: 330x610mm; A02-P-001-A1: 445x850mm; A02-P-001-B: 515x425mm; A02-P-001-B1: 970x570mm; A02-P-001-B2: 970x570mm; A02-P-001-E: | 330x610mm | 615×255mm | |
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Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
| Item | Proposed Device: | Predicate Device (K222669) | | Comments |
| --- | --- | --- | --- | --- |
| | 1420x335mm;
A02-P-001-E2(M):
1230x800mm;
A02-P-001-E2(L):
870x1230mm;
A02-P-001-E4:
1210x370mm;
A02-P-001-F:
470x440mm;
A02-P-001-G:
620x325mm;
A02-P-001-J:
1085x480mm. | | | |
| Operating temperature of the cold wrap | (-18°C~+2°C) (±2°C) | (-18°C~-4°C) (±2°C) | | Note 3 |
| Operating environment | Temperature: 5°C ~ 40°C (41°F ~ 104°F)
Relative humidity: 10% ~ 90%
Atmospheric pressure: 700~1060hpa | Temperature: 5°C ~ 40°C (41°F ~ 104°F)
Relative humidity: 10% ~ 90%
Atmospheric pressure: 700~1060hpa | | Same |
| Transportation & Storage environment | Temperature: -25°C ~55°C (-13°F ~131°F)
Relative humidity: 10% ~ 90%
Atmospheric pressure: 700~1060hpa | Temperature: -25°C~55°C (-13°F ~131°F)
Relative humidity: 10% ~ 90%
Atmospheric pressure: 700~1060hpa | | |
Note 1: The treatment areas of the lower limbs are covered by predicate device. The additional treatment areas of the hips, arms, and back do not raise different questions of safety and effectiveness, and lab bench testing demonstrates acceptable safety and performance. These additional treatment areas have also been included in other legally marketed tube massager devices.
Note 2: Although the subject device is different from predicate devices in the wrap size, the difference in design would not adversely impact safety and effectiveness.
Note 3: The operating temperature range of the cold wrap of the subject device is covered by that of the predicate device. The difference does not raise different questions of safety and effectiveness.
The subject device, Cryopush Cold Compression Device, is substantially equivalent to the predicate device. This conclusion is based upon comparison on intended use, technological characteristics and applicable performance standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.
# 7. Non-clinical Testing
The following data were provided in support of the substantial equivalence determination:
1) Electrical Safety, Electromagnetic Compatibility
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Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) Summary
Product: Cryopush Cold Compression Device
Version: A/1
IEC 60601-1:2005, AMDI:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 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 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
IEC 62133-2:2017, IEC 62133-2:2017/AMD: 2021: 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
AIM 7351731 Rev. 3.00: Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
IEEE ANSI C63.18-2014: American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
2) Software validation
The software document of the subject device was determined according to Guidance for Industry and FDA Staff- Content of Premarket Submissions for Device Software Functions, issued on June 14, 2023
3) Performance
There are no FDA recognized consensus standards for this device. We tested the following items according to our internal standards,
- Product Appearance and Size
- Wrap Performance and Function Test
- Service life verification
- Atmospheric condition testing
- Stacking test
- Vibration test
- Drop test
- Unpacking and inspection
- Stress resistance
- Air pressure release accuracy, rupture and deformities testing
8. Clinical testing
N/A
9. Other information (such as required by FDA guidance/Test)
N/A
10. Conclusions
Non-clinical testing and technological comparison show that the subject device is substantially equivalent to the legally marketed predicate device.
