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

• K Number: K201982
• Device Name: Air compression therapy system FO-3001; Air compression therapy system FO-3008
• Manufacturer: Foshan Hongfeng Co., Ltd
• Date Cleared: 2021-03-25 ( 251 days)
• Product Code: IRP
• Regulation Number: 890.5650

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 Description

Air Pressure Therapy System is 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.

Predicate Devices

K160608

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical air compression and microprocessor control, with no mention of AI or ML terms or functionalities.

Therapeutic

Yes
The device is intended to relieve muscle aches/pains and promote blood circulation, which are therapeutic benefits.

Diagnostic

No
Explanation: The device is described as an "Air compression therapy system" intended to "temporarily relieve minor muscle aches and/or pains, promote blood circulation." Its function involves "sequential squeezing from distal to proximal" to "improve the circulation of blood." This describes a therapeutic device, not one that diagnoses conditions. There is no mention of it detecting, identifying, or monitoring any medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an air pressure sensor, air pump, sleeves, hoses, and a microprocessor, indicating it is a physical system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas." This is a therapeutic or physical therapy application, not a diagnostic one.
• Device Description: The description details a system that applies external pressure to the limbs to improve circulation. This is a physical intervention, not a test performed on biological samples to diagnose a condition.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for clinical purposes. This device operates in vivo (on the body) and provides a physical therapy.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

IRP

Device Description

Air compression therapy system Models FO-3001 and FO-3008: Air Pressure Therapy System is 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

home

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)

Not Applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160608

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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,
Guangdong, China
Tel	86-0757-8392028
Email	[e-mail]
Contact Person	Dongfeng Cheng
Device Identification
Trade Name	Air compression therapy system FO-3001;
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
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
Number | 510k
Number | Sponsor | Predicate Device
Name | Rx or
OTC | Treatment
Time | Pressure
Range |
|-----|----------------------|----------------|----------------------------|---------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 1 | 21 CFR
890.5650 | K160608 | NormaTec
Industries, LP | NormaTec Pulse
and NormaTec
Pulse Pro | OTC | Stays on until the user turns it off or can be set up to
turn off in a range of 10 mins to continuous / User
controlled 10 minutes to 175 minutes or continuous –
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
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
use	Intended for home to temporarily relieve
minor muscle aches and/or pains, promote
blood circulation in treated areas.	The NormaTec Pulse and Pulse Pro is
an air pressure massager intended to
temporarily relieve minor muscle aches
and/or pains, and to temporarily
increase circulation to the treated areas.	Same
Rx or OTC	OTC	OTC	Same
Pressure range	30-110mmHg	30-110mmHg	Same
Treatment
Time	1-60mins	Stays on until the user turns it off or
can be set up to turn off in a range of
10 mins to continuous / User controlled
10 minutes to 175 minutes or
continuous -total time over 4
segments.	Similar
The treatment time of subject device is
smaller than predicate device (K160608)
so the difference of treatment time would
not raise adversely impact on safety and
effectiveness.
Standard	IEC 60601-1-11:2015
IEC 60601-1-2:2014
IEC 60601-1:2005
ISO 10993-10:2010
ISO 10993-5:2009
ISO 10993-12:2012	ES 60601-1,
IEC 60601-1-2,
IEC 60601-1-11	Similar
Mode of
Compression	Sequential	Sequential Gradient, Peristaltic and
Pulsing	Same
Power Source	100-127V/220-240V, 50/60Hz	12 VDC via an IEC 60601-1 compliant
power supply (100-240 VAC input)	Similar
		Optional Integrated rechargeable battery
Power
Consumption	65W	14W	Similar
Dimensions
(WHD)	220190113MM	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
appearance of
sleeves (leg
part)	M:9165cm L:10074cm
XL:110*70cm (Overlapping)	Short: 14" x 43"
Standard: 14" x 48"
Tall: 14" x 60"	Similar
Housing
Materials	Molded ABS enclosure	Molded ABS enclosure	Same
Number of
Chambers	4,6,8 Chambers for each unit	5 or less	Similar
Work Mode	Image: Diagram of different work modes	Sequential mode:
Starting with the distal chamber and
progressing up the proximal chamber, each section compresses and the pressure gradually rises to the	Although the subject device provides six
kinds of work mode, the Mode A is the
same with predicate device (K160608)
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
setup pressure or for 2 seconds, then hold air
for 2 seconds, start deflating; chamber ② start
like ①. Same way till chamber ⑥, pause for 3
seconds, then restart chamber ①②③④⑤⑥
again.		decompresses and the air pressure
drops.
Once the top section decompresses, the
cycle begins again. again.	The treatment pressure range are the same
under different work modes, so the
difference of pressure range would not raise
adversely impact on safety and
effectiveness.
B (Sequential Squeeze Mode): chamber ①
inflating till set up pressure or for 28 seconds,
then hold the pressure, chamber ② inflating,
till setup pressure or for 28 seconds, then
chamber ①② hold pressure in same time,
then chamber ③ start inflating, same way till
after chamber ⑥. Chamber ①②③④⑤⑥
deflating in same time for 3 seconds. Then
repeat.		Normatec Pulse mode:
Starting with the distal zone and
progressing up the proximal zone, one
zone compresses and the pressure
gradually rises to the pre-determined
air pressure level, holds the air of
previous two zone, the other zones do
not hold, until the last zone finished,
deflate the all last three zone then enter
into next cycle.
C (Double Wave Mode: chamber ①②
inflating till setup pressure or for 40 seconds,
hold air for 2 seconds, then start deflating.
Chamber ③④ start inflating till setup pressure
or for 40 seconds, hold air for 2 seconds, then
deflating, same way for chamber ③④ till
chamber ⑤⑥, pause for 3 seconds. Then
repeat.
D (Whole Squeeze Mode): chamber
①②③④⑤⑥ inflating at the same time till
setup pressure or for 90 seconds, then
deflating in the same time for 3 seconds. Then
	Image: Diagram of air pressure
	Image: Diagram of air pressure
	repeat.
E (Combined B + C): sequential squeeze +
double wave
F (Combined A + C + D): normal + double
wave + whole squeeze.
4 and 8 chambers same as 6 chambers above.
Safety feature	Power button on main unit allows user to stop
therapy session at any time	Button on display allows user to stop
or pause therapy session at any time	Same
Technology	Compressor and valve system which
sequentially inflates inflatable chambers	Compressor and valve system which
sequentially inflates inflatable chambers	Same

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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
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
use	Intended for home to temporarily relieve
minor muscle aches and/or pains, promote
blood circulation in treated areas.	The NormaTec Pulse and Pulse Pro is an air pressure
massager intended to temporarily relieve minor
muscle aches and/or pains, and to temporarily increase
circulation to the treated areas.	Same
Rx or OTC	OTC	OTC	Same
Pressure range	30-110mmHg	30-110mmHg	Same
Treatment
Time	1-60mins	Stays on until the user turns it off or can be set up to
turn off in a range of 10 mins to continuous / User
controlled 10 minutes to 175 minutes or continuous
-total time over 4 segments.	Similar
The treatment time of
subject device is smaller
than predicate device
(K160608), so the difference
of treatment time would not
raise adversely impact on
safety and effectiveness.
Standard	IEC 60601-1-11:2015
IEC 60601-1-2:2014
IEC 60601-1:2005
ISO 10993-10:2010
ISO 10993-5:2009	ES 60601-1,
IEC 60601-1-2,
IEC 60601-1-11	Similar
	ISO 10993-12:2012
Mode of
Compression	Sequential	Sequential Gradient, Peristaltic and Pulsing	Same
Power Source	100-127V/220-240V, 50/60Hz	12 VDC via an IEC 60601-1 compliant power supply
(100-240 VAC input) Optional Integrated rechargeable
battery	Similar
Power
Consumption	65W	14W	Similar
Dimensions
(WHD)	240200110MM	4" x 5" x 9"	Similar
Photo	Image: White device with handle	Image: Black handheld device	Similar
Size and
appearance of
sleeves (leg
part)	Image: Leg sleeve	Short: 14" x 43"
Standard: 14" x 48"
Tall: 14" x 60"	Similar
Housing
Materials	Molded ABS enclosure	Molded ABS enclosure	Same
Number of
Chambers	4 Chambers for each unit	5 or less	Similar
Work Mode	Image: [Diagram of chambers inflating]
A (Normal Mode): Chamber ① inflating till
setup pressure or for 2 seconds, then hold air
for 2 seconds, start deflating; chamber ② start
like ①. Same way till chamber ④, pause for 3
seconds, then restart chamber ①②③④ again.
B (Sequential Squeeze Mode): chamber ①
inflating till set up pressure or for 28 seconds,
then hold the pressure, chamber ② inflating,
till setup pressure or for 28 seconds, then
chamber ①② hold pressure in same time,
then chamber ③ start inflating, same way till
after chamber ④. Chamber ①②③④
deflating in same time for 3 seconds. Then
repeat.
C (Double Wave Mode: chamber ①②
inflating till setup pressure or for 40 seconds,
hold air for 2 seconds, then start deflating.
Chamber ③④ start inflating till setup pressure
or for 40 seconds, hold air for 2 seconds, then
deflating.	Sequential mode:
Starting with the distal chamber and progressing up
the proximal chamber, each section compresses and
the pressure gradually rises to the pre-determined air
pressure level, then decompresses and the air pressure
drops.
Once the top section decompresses, the cycle begins
again. again.

Image: [Diagram of sequential mode]

Normatec Pulse mode:
Starting with the distal zone and progressing up the
proximal zone, one zone compresses and the pressure
gradually rises to the pre-determined air pressure
level, holds the air of previous two zone , the other
zones do not hold, until the last zone finished, deflate
the all last three zone then enter into next cycle.

Image: [Diagram of Normatec Pulse mode] | Although the subject device
provides four kinds of work
mode, the Mode A is the
same with predicate device
(K160608), while the other
work modes of proposed
device just have difference
about the inflatable order of
the different chambers. The
treatment pressure range are
the same under different
work modes, so the
difference of pressure range
would not raise adversely
impact on safety and
effectiveness. |
| Safety feature | Power button on main unit allows user to stop therapy session at any time | Button on display allows user to stop or pause therapy session at any time | Same |
| Technology | Compressor and valve system which sequentially inflates inflatable chambers | Compressor and valve system which sequentially inflates inflatable chambers | Same |

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Summary of the Technological Characteristics of the Device

The device meets all the applicable technical requirements of :

• IEC 60601-1-11: 2015 Medical electrical equipment Part 1-1: 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: 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 Compatibility
• ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for ● irritation and skin sensitization, an assessment is made of the potential of the material under test to produce dermal irritation in a relevant animal model
• ISO 10993-5:2009 Biological Evaluation of Medical Device Part 5: Tests for in vitro ● Cytotoxicity
• ISO 10993-12:2012 - Biological Evaluation of Medical Device - Part 12: Sample preparation and reference materials

Conclusion

Based on the indications for use, technological characteristics, and non-clinical performance data, Air compression therapy system Models FO-3001 and FO-3008 (510(K) number) is as safe and effective as the legally marketed predicate devices, NormaTec Pulse and NormaTec Pulse Pro(K160608).