SP-1000, SP-2000

K202395 · Daesung Maref Co., Ltd. · IRP · Sep 1, 2021 · Physical Medicine

Device Facts

• Record ID: K202395
• Device Name: SP-1000, SP-2000
• Applicant: Daesung Maref Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Powered inflatable tube massager; consists of power supply, pump, control unit, and wearable sleeves (leg, arm, lower body). Operates by delivering air from motor to 4-chamber sleeve; chambers inflate sequentially to simulate kneading/stroking. SP-1000 adjusts pressure for all chambers simultaneously; SP-2000 adjusts pressure per channel. User sets time via knob; pump stops when time expires. Pressure control valve allows manual adjustment. Used in professional healthcare and home environments by patients or clinicians. Prevents blood accumulation via repeated inflation/deflation cycles. Benefits patient through muscle pain relief and improved circulation.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and home healthcare environment requirements (IEC 60601-1-11).

Technological Characteristics

Powered inflatable tube massager; 4-chamber sleeve design. Pressure range 0-200mmHg (±15%). Time control 0-30 min. Power: 100-127V or 200-240V, 50/60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Manual pressure/time control via knobs. No software-based algorithm described.

Indications for Use

Indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in healthy individuals.

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

• Rapid Reboot Compression Therapy System (K182668)

Submission Summary (Full Text)

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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

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

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## 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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## 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 :
[e-mail]

- · 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.

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# 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<br>muscle aches and pains and for temporary increase in<br>circulation to the treated areas in people who are in good<br>health. | The Rapid Reboot Compression Therapy System is intended for the<br>temporary relief of minor muscle aches and pains and for the temporary<br>increase in circulation to the treated areas in people who are in good<br>health. The Rapid Reboot Compression Therapy System simulates<br>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<br>Arm sleeve<br>Center body sleeve | Leg attachment<br>Arm attachment<br>Hip attachment |
| Specifications | | |
| Power Source | 100-127V~, 50/60Hz<br>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 :

1) 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

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# 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.