(376 days)
Not Found
No
The device description details a mechanical system of air chambers and pumps controlled by user-adjustable knobs for time and pressure. There is no mention of any algorithms, learning, or data processing that would indicate AI/ML. The performance studies focus on electrical safety and compatibility, not algorithmic performance.
Yes
The device is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation, which are therapeutic purposes. It also performs a physical action (inflation/deflation of sleeves) to achieve these effects.
No
The device description and intended use indicate it is for temporary relief of muscle aches and pains and increased circulation, which are therapeutic functions, not diagnostic ones. It does not mention any ability to detect, identify, or determine a medical condition.
No
The device description explicitly lists hardware components such as a power supply, pump, control unit, and wearable unit (sleeve).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of minor muscle aches and pains and temporary increase in circulation. This is a therapeutic use, not a diagnostic one.
- Device Description: The device operates by applying sequential air pressure to a sleeve to promote circulation. This is a physical therapy or compression therapy mechanism, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SP-1000/2000 is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers which are sequentially inflated from the first air chamber to the fourth chamber.
SP-1000 can adjust the pressure values of all chambers at once. The SP-2000 can adjust the pressure value for each channel. This device is composed of a power supply, a pump, a control unit, and a wearable unit. The power applied from the power supply is applied to the pump. And user can adjust the time through time control knob, during which time power is supplied to the air pump. When the set time is over, the pump will stop working. Air pump creates air pressure and transmits it to the Synchro motor. The air delivered to the synchro motor distributes the air to each channel of the sleeve. And there is a pressure control valve between the synchro motor, the user can adjust the pressure of each sleeve through the pressure control knob. The sleeve prevents blood from accumulating by repeatedly applying inflation/deflation to the wearing to the type of the sleeve, it can apply to the leg, lower body, and arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, lower body, and arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare environment & Home environment
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 Test Summary: The SP-1000 / SP-2000 comply with voluntary standards for electromagnetic compatibility, use in the home healthcare environment and usability.
The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance
The SP-1000 / SP-2000 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance
- 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 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
Clinical Test Summary: Clinical testing was not required to demonstrate the substantial equivalence of the SP-1000 / SP-2000 to its predicate device
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)
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.
September 1, 2021
DaeSung Maref Co., Ltd % Do Gyun Lim Senior Consultant Global Medical Standard Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul, 03909 Korea. South
Re: K202395
Trade/Device Name: Sp-1000, Sp-2000 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: September 9, 2020 Received: September 10, 2020
Dear Do Gyun Lim:
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.
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
1
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 (OS) 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 mediation-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,
For
Amber Ballard Assistant Director 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
2
Indications for Use
510(k) Number (if known) K202395
Device Name SP-1000, SP-2000
Indications for Use (Describe)
SP-1000/2000 is indicated for the temporary relief of minor muscle aches and pains and for temporaryincrease in circulation to the treated areas in people who are in good health.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K202395 510(K) Summary
1. Data Prepared [21 CFR 807.92(a)(a)|
May 08, 2021
2. Submitter's Information [21 CFR 807.92(a)(1)]
-
Name of Manufacturer :
DAESUNG MAREF CO., LTD. -
Address :
298-24, Gongdan-ro Gunpo-si, Gyeonggido Republic of Korea -
Contact Name :
Hyoung Ju, Cho -
Telephone No. :
82-31-459-7211 -
Fax No. :
82-31-459-7215 -
Email Adress :
rndra@dsmaref.com -
· Registration No. :
- 3004116008
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)|
| Trade / Device Name | SP-1000, SP-2000 |
|---|---|
| Common Name | Powered Inflatable Tube Massager |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Powered Inflatable Tube Massager |
| Regulation Class | II |
| Product Code | IRP |
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|
Predicate Device
-
510(k) Number :
K182668 -
Applicant :
Rapid Reboot Recovery Product, LLC -
Trade / Device Name :
Rapid Reboot Compression Therapy System -
· Regulation Number :
21 CFR 890.5650 -
· Regulation Name :
Powered Inflatable Tube Massager -
· Regulation Class:
- II
-
Product Code:
IRP
Predicate device has not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
Operating principal of this device is that the air output from the air motor is delivered to a sleeve composed of four air chambers which are sequentially inflated from the first air chamber to the fourth chamber.
SP-1000 can adjust the pressure values of all chambers at once. The SP-2000 can adjust the pressure value for each channel. This device is composed of a power supply, a pump, a control unit, and a wearable unit. The power applied from the power supply is applied to the pump. And user can adjust the time through time control knob, during which time power is supplied to the air pump. When the set time is over, the pump will stop working. Air pump creates air pressure and transmits it to the Synchro motor. The air delivered to the synchro motor distributes the air to each channel of the sleeve. And there is a pressure control valve between the synchro motor, the user can adjust the pressure of each sleeve through the pressure control knob. The sleeve prevents blood from accumulating by repeatedly applying inflation/deflation to the wearing to the type of the sleeve, it can apply to the leg, lower body, and arm.
4
K202395 510(K) Summary
6. Indications For Use [21 CFR 807(a)(5)]
SP-1000/2000 is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health.
7. Determination of Substantial Equivalence
Summary of technological characteristics of the device compared to the predicate device. [21CFR
807.92(a)(6)]
The SP-1000/2000 is substantially equivalent to legally marketed predicate device (Rapid Reboot Compression Therapy System) with respect to indications for use and technology characteristics. The table below presents comparisons for devices:
[Table 1. Comparison of Proposed Device to Predicate Devices]
| Proposed Device | Predicate Device | |
|---|---|---|
| Model Name | SP-1000 / SP-2000 | Rapid Reboot Compression Therapy System |
| 510(k) Number | K202395 | K182668 |
| Manufacturer | DAESUNG MAREF CO., LTD. | Raid Reboot Recovery Product, LLC |
| Product Code | IRP | IRP |
| Device Class | II | II |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 |
| Regulation Name | Powered Inflatable Tube Massager | Powered Inflatable Tube Massager |
| Indications For Use | SP-1000/2000 is indicated for the temporary relief of minor | |
| muscle aches and pains and for temporary increase in | ||
| circulation to the treated areas in people who are in good | ||
| health. | The Rapid Reboot Compression Therapy System is intended for the | |
| temporary relief of minor muscle aches and pains and for the temporary | ||
| increase in circulation to the treated areas in people who are in good | ||
| health. The Rapid Reboot Compression Therapy System simulates | ||
| kneading and stroking of tissues by using an inflatable garment. | ||
| Intended Use environment | Professional healthcare environment & Home environment | Clinics, hospital, athlete training, and home environments |
| Type of Use | OTC | OTC |
| Accessories | Leg sleeves | |
| Arm sleeve | ||
| Center body sleeve | Leg attachment | |
| Arm attachment | ||
| Hip attachment | ||
| Specifications | ||
| Power Source | 100-127V~, 50/60Hz | |
| 200-240V~, 50/60Hz | 100V, 60 Hz | |
| Time | 0-30 min | 0-30 min |
| Pressure | 0-200mmHg ± 15% mmHg | 0-200mmHg |
| Number of chamber | 4 | 4 |
The table also provides rationale for a little difference in support of substantial equivalence to the Predicate devices.
[Table 2. Little difference with Predicate Device]
Justification to Support Substantial Equivalence
There are no significant differences between SP-1000 and the predicate devices that would adversely affect its use. The subject device declares the safety and effectiveness of the device through tests for appropriate standards and the accessories, though named differently, are used on the same anatomical locations as the predicate device. Therefore, It is substantially equivalent in indications for use and technology characteristics.
Non-Clinical Test Summary
The SP-1000 / SP-2000 comply with voluntary standards for electromagnetic compatibility, use in the home healthcare environment and usability.
The following data were provided in support of the substantial equivalence determination :
- Electrical Safety, Electromagnetic Compatibility and Performance
The SP-1000 / SP-2000 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- IEC 60601 : 2005/A1:2012, Medical Electrical Equipment:Part 1: General Requirements for Basic Safety and Essential Performance
- · 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 60601-1-11:2015, Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Per formance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
5
K202395 510(K) Summary
Clinical Test Summary
Clinical testing was not required to demonstrate the substantial equivalence of the SP-1000 / SP-2000 to its predicate device
8. Conclusion [21 CFR 807.92(b)(3)]
The SP-1000 / SP-2000 have similar intended use and technical characteristics to the predicate devices. Based on that information, we conclude that the differences between the proposed device and predicate devices do not introduce a new intended use and do not raise of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.