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

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. 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)

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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.

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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 ([e-mail]) or phone [phone] 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

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#### 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)

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## 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<br>Road (West), Wenjiang District, Chengdu 611137 Sichuan<br>P.R.China |
| Phone No. | TEL: [phone] |
| 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,<br>Liuxian Avenue, Xili Town, Nanshan District, Shenzhen,<br>Guangdong Province, China |
| 卓远天成 | |
| Phone No. | [phone] |
| Contact person | Liz Li |
| Contact person's e-mail | [e-mail]; [e-mail] |
| 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<br>IME |
| Regulation No. | 21 CFR 890.5650<br>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 |

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### 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:<br>(K222669) | | Predicate Device:<br>(K193354) | Comments |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Regulation<br>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<br>use/Indications<br>for use | The Cryopush Cold<br>Compression Device<br>is indicated for the<br>temporary relief of<br>minor muscle aches<br>and pains.<br>The device is | The Cryopush<br>A02-P-002 is<br>indicated for the<br>temporary relief of<br>minor muscle aches<br>and pains.<br>The device is | The Air Compression<br>Therapy Device is<br>indicated for the<br>temporary relief of minor<br>muscle aches and pains<br>and for temporary<br>increase in circulation to<br>the treated areas in | Substantial<br>Equivalence |
| Item | Proposed Device:<br>(K222669) | | Predicate Device:<br>(K193354) | Comments |
| | indicated for<br>temporary increase in<br>circulation of the<br>treated areas in<br>people who are in<br>good health, and<br>simulates kneading<br>and stroking of<br>tissues using by an<br>inflatable wrap.<br>The cold pack is<br>indicated for localized<br>therapy in situations<br>where cold<br>temperature therapy<br>is necessary or<br>desirable. | indicated for<br>temporary increase<br>in circulation of the<br>treated areas in<br>people who are in<br>good health, and<br>simulates kneading<br>and stroking of<br>tissues using by an<br>inflatable wrap. | people who are in good<br>health. The Air<br>Compression Therapy<br>Device simulates<br>kneading and stroking of<br>tissues by using an<br>inflatable garment. | |
| Treatment<br>area/Structure of<br>Sleeves | Low limbs (Calf and upper leg) | | Low limbs (Foot, calf and<br>upper leg) | Similar |
| OTC or Rx | OTC | | OTC | Same |
| Environment of<br>Use | Clinics, hospital, athlete training, and home<br>environments | | Clinics, hospital, athlete<br>training, and home<br>environments | Same |
| Power source | 100-240V~50/60Hz | | 100~240V 50/60Hz | Same |
| Working Time | 10min, 20 min, 30<br>min, 40 min, 50 min,<br>60 min, 70 min, 80<br>min, 90 min, 100 min,<br>110 min, 120 min,<br>default as 30min | 10min, 20 min, 30<br>min, 40 min, 50 min,<br>60 min, default as<br>30min | 20 minutes | Substantial<br>Equivalence |
| Pressure range | 0-100mmHg | 0~215 mmHg | 0~240 mmHg | |
| Pressure levels | 20mmHg,40<br>mmHg,60 mmHg,80<br>mmHg,100 mmHg. | 100mmHg, 160<br>mmHg, 215mmHg; | 150mmHg; 185mmHg;<br>215mmHg | Substantial<br>Equivalence |
| Pressure error<br>range | ±15mmHg | ±20mmHg | ±25mmHg | |
| Keep time | 10s | | 1-5s | Substantial |
| Deflation time | 20s | | 1-5s | Equivalence |
| Working process | The pressure of the<br>chamber gradually<br>rises to the<br>pre-determined air<br>pressure level, then<br>decompresses and<br>the air pressure | Starting with the<br>lower chamber and<br>progressing up the<br>upper chamber,<br>each section<br>compresses and the<br>pressure gradually<br>rise to the<br>pre-determined air | Mode 1:Starting with the<br>foot chamber and<br>progressing up the thigh<br>chamber, each section<br>compresses and the<br>pressure gradually rises<br>to the pre-determined air<br>pressure level, then<br>decompresses and the | Similar |
| Item | Proposed Device:<br>(K222669) | Predicate Device:<br>(K193354) | Comments | |
| | drops. The cycle<br>begins again. | air pressure drops. Once<br>the thigh section<br>decompresses, the cycle<br>begins again.<br>Mode 2:Starting with the<br>foot chamber and<br>progressing up the thigh,<br>each section compresses<br>and the pressure<br>gradually rises to the<br>pre-determined air<br>pressure level, holds the<br>air until the entire<br>garment is compressed.<br>All three sections then<br>decompress<br>simultaneously and the<br>air pressure drops, then<br>cycle begins again.<br>Mode 3:include two<br>stages, stage1: it works<br>according to the method<br>of mode 1, after the stage<br>1 is completed, it goes to<br>stage 2(working<br>according to the method<br>of mode 2) without<br>interruption time until<br>finish the stage 2, then<br>enter next cycle without<br>interruption.<br>Mode1⇌Mode2<br>The pressure sequence<br>of mode 3 combines<br>mode 1 and mode 2 | | |
| Noise level | ≤ 55dB | ≤ 65dB | Similar | |
| Wrap Material | Nylon with a PVC laminate | Nylon with a<br>Polyurethane laminate | Different | |
| Patient contact | Non-conductive attachments | Non-conductive<br>attachments | Same | |
| Appearance | Image: wrap with controller | Image: wrap with controller | Different | |
| Single Wrap<br>weight | 480g | 210g | 4.6 pounds (2023g) | |
| Wrap Size | 330x610mm | 615x255mm | 72*26cm | |
| Item | Proposed Device:<br>(K222669) | Predicate Device:<br>(K193354) | Comments | |
| Cold pack<br>weight | 1030g (±10%) | NA | Different | |
| Cold pack<br>Size | 300 x 570mm | NA | | |
| Operating<br>environment | Temperature: 5℃~ 40℃ (41°F ~ 104°F)<br>Relative humidity: 10% ~ 90%<br>Atmospheric pressure: 700~1060hpa | Temperature: 5°C- 40°C,<br>Humidity: 5%- 90%<br>non-condensing | | |
| Transportation &<br>Storage<br>environment | Temperature: -25°C~55°C (-13°F ~ 131°F)<br>Relative humidity: 10% ~ 90%<br>Atmospheric pressure: 700~1060hpa | Temperature: - 20 °C<br>~55℃;<br>Humidity:5%-90%<br>non-condensing<br>Atmospheric<br>Pressure:75kPa-106kPa | Similar | |

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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

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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).