Air compression therapy system FO-3001; Air compression therapy system FO-3008

K201982 · Foshan Hongfeng Co., Ltd. · IRP · Mar 25, 2021 · Physical Medicine

Device Facts

• Record ID: K201982
• Device Name: Air compression therapy system FO-3001; Air compression therapy system FO-3008
• Applicant: Foshan Hongfeng Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Mar 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.

Device Story

Air compression therapy system (models FO-3001, FO-3008) consists of air pump, air pressure sensor, and inflatable sleeves connected via hoses. Device operates by sequentially inflating and deflating air chambers in sleeves to provide compression massage from limb end to body center. System controlled by microprocessor and sensor; user adjusts pressure settings. Used in home environment by patients for temporary relief of minor muscle aches/pains and circulation promotion. Output is mechanical compression massage. Benefits include improved blood circulation and muscle pain relief. Safety feature includes power button to stop therapy session.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2) and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-12).

Technological Characteristics

Molded ABS enclosure; compressor and valve system for sequential inflation; 4, 6, or 8 chambers; pressure range 30-110mmHg; power 100-240V AC; microprocessor-controlled; standards: IEC 60601-1:2005, IEC 60601-1-11:2015, IEC 60601-1-2:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-12:2012.

Indications for Use

Indicated for home use to temporarily relieve minor muscle aches and/or pains and promote blood circulation in treated areas.

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

• NormaTec Pulse and NormaTec Pulse Pro (K160608)

Submission Summary (Full Text)

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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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 25, 2021

Foshan Hongfeng Co., Ltd % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K201982

Trade/Device Name: Air compression therapy system FO-3001; Air compression therapy system FO-3008 Regulation Number: 21 CFR 890.5650

Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 17, 2020 Received: July 17, 2020

Dear Sam Lin:

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 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.

Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K201982

#### Device Name

Air compression therapy system FO-3001; Air compression therapy system FO-3008

#### Indications for Use (Describe)

Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.

| 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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| Type of Submission | Traditional |
|---------------------------|-----------------------------------------------------------------------------------|
| Date Prepared | February 4, 2021 |
| Submission Sponsor | |
| Manufacturer Name | FOSHAN HONGFENG CO.,LTD. |
| Address | No.4-2 Leqiang Road, Leping Sanshui, Foshan,<br>Guangdong, China |
| Tel | 86-0757-8392028 |
| Email | [e-mail] |
| Contact Person | Dongfeng Cheng |
| Device Identification | |
| Trade Name | Air compression therapy system FO-3001;<br>Air compression therapy system FO-3008 |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Power inflatable tube massager |
| Device Classification | Class II |
| Product Code | IRP |
| Panel | Physical Medicine |
| Previous Submissions | None |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co.,Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New<br>District, Shanghai, China |
| Tel | 86-15626132181 |
| Email | [e-mail] |
| Contact Person | Sam Lin |

Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.

#### Device Description

Indications for Use of the Device

Air compression therapy system Models FO-3001 and FO-3008: Air Pressure Therapy System is Section[006] Page 1 of 13

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consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.

### Performance Testing - Clinical

Not Applicable.

Performance Testing - Animal

Not Applicable.

[Remainder of page left intentionally blank]

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## Table 6A: Predicate Device Information

| No. | Regulation<br>Number | 510k<br>Number | Sponsor | Predicate Device<br>Name | Rx or<br>OTC | Treatment<br>Time | Pressure<br>Range |
|-----|----------------------|----------------|----------------------------|---------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 1 | 21 CFR<br>890.5650 | K160608 | NormaTec<br>Industries, LP | NormaTec Pulse<br>and NormaTec<br>Pulse Pro | OTC | Stays on until the user turns it off or can be set up to<br>turn off in a range of 10 mins to continuous / User<br>controlled 10 minutes to 175 minutes or continuous –<br>total time over 4 segments | 30-110mmHg |

### Table 6B: Differences between Models

| Characteristic | Air Compression Therapy System: FO-3001 | Air Compression Therapy System: FO-3008 |
|--------------------------------|-----------------------------------------|-----------------------------------------|
| Indications for use | × | × |
| OTC | × | × |
| Device Pressure Range | × | × |
| Treatment Time | × | × |
| Standard | × | × |
| Mode of Compression | × | × |
| Power Source | × | × |
| Power Consumption | × | × |
| Size and appearance of sleeves | × | × |
| Housing Materials | × | × |

Note: *"×" means same.

Section[006]
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| Safety Feature | | |
|--------------------|-----------------------------------------|-----------------------------------------|
| Safety Feature | X | X |
| Technology | X | X |
| Dimensions | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Photo | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Number of Chambers | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Work Mode | Different, see the Table 6C for details | Different, see the Table 6D for details |

# Table 6C: Summary of Comparison of FO-3001

| | Subject Device | Predicate Device | Differences Discussion |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Air compression therapy system: FO-3001 | NormaTec Pulse and NormaTec Pulse<br>Pro | N/A |
| 510(k) number | K160608 | K160608 | N/A |
| Manufacturer | FOSHAN HONGFENG CO.,LTD. | NormaTec Industries, LP | N/A |
| Product Regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation Class | 2 | 2 | Same |
| Product Code | IRP | IRP | Same |
| Indications for<br>use | Intended for home to temporarily relieve<br>minor muscle aches and/or pains, promote<br>blood circulation in treated areas. | The NormaTec Pulse and Pulse Pro is<br>an air pressure massager intended to<br>temporarily relieve minor muscle aches<br>and/or pains, and to temporarily<br>increase circulation to the treated areas. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 30-110mmHg | 30-110mmHg | Same |
| Treatment<br>Time | 1-60mins | Stays on until the user turns it off or<br>can be set up to turn off in a range of<br>10 mins to continuous / User controlled<br>10 minutes to 175 minutes or<br>continuous -total time over 4<br>segments. | Similar<br>The treatment time of subject device is<br>smaller than predicate device (K160608)<br>so the difference of treatment time would<br>not raise adversely impact on safety and<br>effectiveness. |
| Standard | IEC 60601-1-11:2015<br>IEC 60601-1-2:2014<br>IEC 60601-1:2005<br>ISO 10993-10:2010<br>ISO 10993-5:2009<br>ISO 10993-12:2012 | ES 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-11 | Similar |
| Mode of<br>Compression | Sequential | Sequential Gradient, Peristaltic and<br>Pulsing | Same |
| Power Source | 100-127V/220-240V, 50/60Hz | 12 VDC via an IEC 60601-1 compliant<br>power supply (100-240 VAC input) | Similar |
| | | Optional Integrated rechargeable battery | |
| Power<br>Consumption | 65W | 14W | Similar |
| Dimensions<br>(W*H*D) | 220*190*113MM | 4" x 5" x 9" | Similar |
| Photo | Image: Photo of a black device with buttons and a handle | Image: Photo of a black device with a screen | Similar |
| Size and<br>appearance of<br>sleeves (leg<br>part) | M:91*65cm L:100*74cm<br>XL:110*70cm (Overlapping) | Short: 14" x 43"<br>Standard: 14" x 48"<br>Tall: 14" x 60" | Similar |
| Housing<br>Materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of<br>Chambers | 4,6,8 Chambers for each unit | 5 or less | Similar |
| Work Mode | Image: Diagram of different work modes | Sequential mode:<br>Starting with the distal chamber and<br>progressing up the proximal chamber, each section compresses and the pressure gradually rises to the | Although the subject device provides six<br>kinds of work mode, the Mode A is the<br>same with predicate device (K160608)<br>while the other work modes of subject the device just have difference about the |
| 6 chambers: | | pre-determined air pressure level, then | inflatable order of the different chambers |
| A (Normal Mode): Chamber ① inflating till<br>setup pressure or for 2 seconds, then hold air<br>for 2 seconds, start deflating; chamber ② start<br>like ①. Same way till chamber ⑥, pause for 3<br>seconds, then restart chamber ①②③④⑤⑥<br>again. | | decompresses and the air pressure<br>drops.<br>Once the top section decompresses, the<br>cycle begins again. again. | The treatment pressure range are the same<br>under different work modes, so the<br>difference of pressure range would not raise<br>adversely impact on safety and<br>effectiveness. |
| B (Sequential Squeeze Mode): chamber ①<br>inflating till set up pressure or for 28 seconds,<br>then hold the pressure, chamber ② inflating,<br>till setup pressure or for 28 seconds, then<br>chamber ①② hold pressure in same time,<br>then chamber ③ start inflating, same way till<br>after chamber ⑥. Chamber ①②③④⑤⑥<br>deflating in same time for 3 seconds. Then<br>repeat. | | Normatec Pulse mode:<br>Starting with the distal zone and<br>progressing up the proximal zone, one<br>zone compresses and the pressure<br>gradually rises to the pre-determined<br>air pressure level, holds the air of<br>previous two zone, the other zones do<br>not hold, until the last zone finished,<br>deflate the all last three zone then enter<br>into next cycle. | |
| C (Double Wave Mode: chamber ①②<br>inflating till setup pressure or for 40 seconds,<br>hold air for 2 seconds, then start deflating.<br>Chamber ③④ start inflating till setup pressure<br>or for 40 seconds, hold air for 2 seconds, then<br>deflating, same way for chamber ③④ till<br>chamber ⑤⑥, pause for 3 seconds. Then<br>repeat. | | | |
| D (Whole Squeeze Mode): chamber<br>①②③④⑤⑥ inflating at the same time till<br>setup pressure or for 90 seconds, then<br>deflating in the same time for 3 seconds. Then | | | |
| | Image: Diagram of air pressure | | |
| | Image: Diagram of air pressure | | |
| | | | |
| | repeat.<br>E (Combined B + C): sequential squeeze +<br>double wave<br>F (Combined A + C + D): normal + double<br>wave + whole squeeze.<br>4 and 8 chambers same as 6 chambers above. | | |
| Safety feature | Power button on main unit allows user to stop<br>therapy session at any time | Button on display allows user to stop<br>or pause therapy session at any time | Same |
| Technology | Compressor and valve system which<br>sequentially inflates inflatable chambers | Compressor and valve system which<br>sequentially inflates inflatable chambers | Same |

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Section[006]
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Section[006]
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## Table 6D: Summary of Comparison of FO-3008

| | Subject Device | Predicate Device | Differences Discussion |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Air compression therapy system: FO-3008 | NormaTec Pulse and NormaTec Pulse Pro | N/A |
| 510(k) number | | K160608 | N/A |
| Manufacturer | FOSHAN HONGFENG CO.,LTD. | NormaTec Industries, LP | N/A |
| Product<br>Regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification<br>Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation<br>Class | 2 | 2 | Same |
| Product Code | IRP | IRP | Same |
| Indications for<br>use | Intended for home to temporarily relieve<br>minor muscle aches and/or pains, promote<br>blood circulation in treated areas. | The NormaTec Pulse and Pulse Pro is an air pressure<br>massager intended to temporarily relieve minor<br>muscle aches and/or pains, and to temporarily increase<br>circulation to the treated areas. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 30-110mmHg | 30-110mmHg | Same…