(90 days)
Not Found
No
The description focuses on mechanical compression and cold therapy, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, which are therapeutic claims.
No
The device is indicated for temporary relief of muscle aches and pains and increased circulation, not for diagnosing medical conditions.
No
The device description clearly states it consists of a "main unit and wraps" which are physical components that simulate kneading and stroking using "inflatable pressure wraps." It also mentions a "cold pack" as part of one model. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device for physical therapy (cold compression, temporary relief of muscle aches and pains, increasing circulation, simulating massage). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a mechanical device that applies pressure and cold to the body. It does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is the hallmark of an IVD.
- Lack of IVD characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP, IME
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℃).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Low limbs (Calf and upper leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
-
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
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 -
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 -
Performance
Tested the following items according to internal standards:
- Product Appearance and Size
- Wrap Performance
- Function Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the 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)
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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 |
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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:
(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 | 100-240V50/60Hz | | 100240V 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 | 0215 mmHg | 0240 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: 7001060hpa | Temperature: 5°C- 40°C,55°C (-13°F ~ 131°F)
Humidity: 5%- 90%
non-condensing | | |
| Transportation &
Storage
environment | Temperature: -25°C
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:
- 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
- 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
- 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).