Who is the manufacturer of Cryopush Cold Compression Device?

Chengdu Cryo-Push Medical Technology Co.,Ltd filed the 510(k) submission for Cryopush Cold Compression Device (K222669).

What is the FDA product code for Cryopush Cold Compression Device?

IRP. It is classified under 21 CFR 890.5650 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Cryopush Cold Compression Device?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cryopush Cold Compression Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cryopush Cold Compression Device

K222669 · Chengdu Cryo-Push Medical Technology Co.,Ltd · IRP · Dec 5, 2022 · Physical Medicine

Device Facts

Record ID	K222669
Device Name	Cryopush Cold Compression Device
Applicant	Chengdu Cryo-Push Medical Technology Co.,Ltd
Product Code	IRP · Physical Medicine
Decision Date	Dec 5, 2022
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. 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.

Device Story

Device consists of main unit and inflatable wraps; simulates kneading/stroking of tissues via air chamber inflation/deflation cycles. Used in clinics, hospitals, athlete training, or home environments by patients or clinicians. A02-P-001 includes cold pack for localized cold therapy (-18°C to -4°C). User controls pressure and treatment time via hand controller. Output is mechanical compression; cold pack provides thermal therapy. Benefits include pain relief and increased circulation. Device operates on 100-240V AC.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), software validation, and internal performance testing (appearance, size, wrap performance, function).

Technological Characteristics

Powered inflatable tube massager. Materials: Nylon with PVC laminate. Energy: 100-240V 50/60Hz. Dimensions: A02-P-001 (330x610mm), A02-P-002 (615x255mm). Pressure range: 0-215 mmHg. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2.

Indications for Use

Indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation in healthy individuals. A02-P-001 includes a cold pack for 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 Device (K193354)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 5, 2022 Chengdu Cryo-Push Medical Technology Co., Ltd % Liz Li Counselor Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A. Zhonhhuan Times Square Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China Re: K222669 Trade/Device Name: Cryopush Cold Compression Device Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: September 6, 2022 Received: September 6, 2022 Dear Liz Li: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K222669 Device Name Cryopush Cold Compression Device #### Indications for Use (Describe) A02-P-001: 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. #### A02-P-002: 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary ### 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 | | 卓远天成 | | | Phone No. | +86 755-86069197 | | Contact person | Liz Li | | Contact person's e-mail | liz@cefda.com; grace@cefda.com | | Website | http://www.cefda.com | ### 2. Device information | Trade name | Cryopush Cold Compression Device | |---------------------|------------------------------------| | Classification | II | | Classification name | Massager, Powered Inflatable Tube | | Product code | IRP IME | | Regulation No. | 21 CFR 890.5650 21 CFR 890.5700 | #### 3. Legally Marketed Predicate Device | Trade Name | Air Compression Therapy Device | |---------------|------------------------------------------| | 510(k) Number | K193354 | | Product Code | IRP | | Manufacturer | Shenzhen Dongjilian Electronics Co., Ltd | {4}------------------------------------------------ ### 4. Device Description Cryopush Cold Compression Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and 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 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃). #### 5. Intended use #### A02-P-001: 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. #### A02-P-002: 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. ### 6. Substantial Equivalence Comparison | Item | Proposed Device: (K222669) | | Predicate Device: (K193354) | Comments | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Regulation number | 890.5650 | | 890.5650 | Same | | Classification | II | | II | Same | | Model | A02-P-001 | A02-P-002 | S9019 | Same | | Product Code | IRP, IME | | IRP | | | 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 | The Cryopush A02-P-002 is indicated for the temporary relief of minor muscle aches and pains. The device is | The Air Compression Therapy Device is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in | Substantial Equivalence | | Item | Proposed Device: (K222669) | | Predicate Device: (K193354) | Comments | | | 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. | 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. | people who are in good health. The Air Compression Therapy Device simulates kneading and stroking of tissues by using an inflatable garment. | | | Treatment area/Structure of Sleeves | Low limbs (Calf and upper leg) | | Low limbs (Foot, calf and upper leg) | Similar | | 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, default as 30min | 10min, 20 min, 30 min, 40 min, 50 min, 60 min, default as 30min | 20 minutes | Substantial Equivalence | | Pressure range | 0-100mmHg | 0~215 mmHg | 0~240 mmHg | | | Pressure levels | 20mmHg,40 mmHg,60 mmHg,80 mmHg,100 mmHg. | 100mmHg, 160 mmHg, 215mmHg; | 150mmHg; 185mmHg; 215mmHg | Substantial Equivalence | | Pressure error range | ±15mmHg | ±20mmHg | ±25mmHg | | | Keep time | 10s | | 1-5s | Substantial | | Deflation time | 20s | | 1-5s | Equivalence | | Working process | The pressure of the chamber gradually rises to the pre-determined air pressure level, then decompresses and the air pressure | Starting with the lower chamber and progressing up the upper chamber, each section compresses and the pressure gradually rise to the pre-determined air | Mode 1:Starting with the foot chamber and progressing up the thigh chamber, each section compresses and the pressure gradually rises to the pre-determined air pressure level, then decompresses and the | Similar | | Item | Proposed Device: (K222669) | Predicate Device: (K193354) | Comments | | | | drops. The cycle begins again. | air pressure drops. Once the thigh section decompresses, the cycle begins again. Mode 2:Starting with the foot chamber and progressing up the thigh, each section compresses and the pressure gradually rises to the pre-determined air pressure level, holds the air until the entire garment is compressed. All three sections then decompress simultaneously and the air pressure drops, then cycle begins again. Mode 3:include two stages, stage1: it works according to the method of mode 1, after the stage 1 is completed, it goes to stage 2(working according to the method of mode 2) without interruption time until finish the stage 2, then enter next cycle without interruption. Mode1⇌Mode2 The pressure sequence of mode 3 combines mode 1 and mode 2 | | | | Noise level | ≤ 55dB | ≤ 65dB | Similar | | | Wrap Material | Nylon with a PVC laminate | Nylon with a Polyurethane laminate | Different | | | Patient contact | Non-conductive attachments | Non-conductive attachments | Same | | | Appearance | Image: wrap with controller | Image: wrap with controller | Different | | | Single Wrap weight | 480g | 210g | 4.6 pounds (2023g) | | | Wrap Size | 330x610mm | 615x255mm | 72*26cm | | | Item | Proposed Device: (K222669) | Predicate Device: (K193354) | Comments | | | Cold pack weight | 1030g (±10%) | NA | Different | | | Cold pack Size | 300 x 570mm | NA | | | | Operating environment | Temperature: 5℃~ 40℃ (41°F ~ 104°F) Relative humidity: 10% ~ 90% Atmospheric pressure: 700~1060hpa | Temperature: 5°C- 40°C, Humidity: 5%- 90% non-condensing | | | | Transportation & Storage environment | Temperature: -25°C~55°C (-13°F ~ 131°F) Relative humidity: 10% ~ 90% Atmospheric pressure: 700~1060hpa | Temperature: - 20 °C ~55℃; Humidity:5%-90% non-condensing Atmospheric Pressure:75kPa-106kPa | Similar | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ The subject device sequentially inflates and deflation inflatable chambers to simulate kneading and stroking of tissues for the temporary relief of minor muscle aches and pains. Prolonged use will not cause circulation issues. The cold pack of A02-P-001 provides cold therapy for body surfaces, which can make capillaries constrict, reduce local congestion, can make nerve endings less sensitive and reduce pain. Within 30 minutes of operation, the temperature of the cold pack will be from -18℃ to -4℃, which will not bring potential harm to the patient. Its code is IME and the submission type is 510(K) Exempt. So, the difference of cold pack would not raise adversely impact on safety and effectiveness. Although the treatment time range of subject device is 0 to 120mins, which seems to be larger than the predicate devices, but the default value is 30min which is suitable for daily use. In the process of use, the user can start or stop at any time by the power button on the hand controller, so the difference of Treatment time would not raise adversely impact on safety and effectiveness. The subject device, Cryopush Cold Compression Device, is substantially equivalent to the predicate device (K193354). This conclusion is based upon comparison on intended use, technological characteristics and performances. 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 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 {8}------------------------------------------------ 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 2) Software validation The software document of the subject device was determined according to Guidance for Industry and FDA Staff- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005 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 - Function Test #### 8. Clinical testing N/A #### 9. Other information (such as required by FDA guidance/Test) N/A #### 10. Conclusions The subject device is substantially equivalent to the legally marketed predicate device Air Compression Therapy Device (K193354).

Cryopush Cold Compression Device

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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Cryopush Cold Compression Device

Device Facts

Indications for Use

Device Story

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Identification

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Submission Summary (Full Text)

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