Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a microprocessor and sensor controlling the device's function, but there is no mention of AI, ML, or any learning or adaptive capabilities. The operation appears to be based on pre-programmed sequential inflation/deflation cycles.

Therapeutic

Yes
The device is intended to temporarily relieve minor muscle aches and/or pains and increase circulation, which are therapeutic claims. It also references predicate devices that are medical in nature (e.g., Air Compression Therapy Device).

Diagnostic

No

Explanation: The device description states its intended use is for temporary relief of muscle aches and pain and to increase circulation, which are therapeutic functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components such as an air pressure sensor, air pump, and sleeves, which work together as a unit. This indicates it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Leg Massager described is a physical therapy device that applies air pressure to the legs to relieve muscle aches and improve circulation. It does not perform any tests on biological samples.
Intended Use: The intended use clearly states it's for temporary relief of muscle aches and increasing circulation, not for diagnosing any condition.

The information provided about the device's function, intended use, and lack of mention of any testing on biological samples all point away from it being an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Product codes

IRP, IRT

Device Description

Leg Massager (Models:RP-ALM070H, RP-ALM071H) 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.

Leg Massager (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

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 Found

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

Not Found

Predicate Device(s)

K193354, K223729

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

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

November 20, 2024

Shenzhen Ruiyi Business Technology Co., Ltd. % Libray Zhang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K232965

Trade/Device Name: Leg Massager (Models: RP-ALM070H, RP-ALM071H) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP. IRT Dated: September 30, 2024 Received: September 30, 2024

Dear Libray Zhang:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

2

assistance/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,

Heather L. Dean -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K232965

Device Name

Leg Massager (Models:RP-ALM070H, RP-ALM071H)

Indications for Use (Describe)

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K232965

Type of Submission	Traditional
Date Prepared	Jun 27, 2023
Submission Sponsor
Manufacturer Name	Shenzhen Ruiyi Business Technology Co., Ltd.
Address	Qianhai Complex A201, Qianwan Road 1, Qianhai
Shenzhen-Hong Kong Cooperation Zone,
Shenzhen, China
Tel	86-18566621145
Email	derric@renpho.com
Contact Person	derric bai
Application Correspondent
Company Name	Shanghai Spica Management Consulting Co., Ltd.
Address	609 Room, No.133 Shengang Avenue, Pudong New
District, Shanghai, China
Tel	86-13020102321
Email	Libray@spicagloble.com
Contact Person	Libray Zhang
Device Identification
Trade Name	Leg Massager (Models:RP-ALM070H, RP-ALM071H)
Regulation Number	21 CFR 890.5650
Classification Name	Massager, Powered Inflatable Tube
Device Classification	Class II
Panel	Physical Medicine
Product Code	IRP
Previous Submissions	None

Indications for Use

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Device Description

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Leg Massager (Models:RP-ALM070H, RP-ALM071H) 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.

Leg Massager (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.

Predicate Device Information

Sponsor	Shenzhen Dongjilian Electronics Co., Ltd.
Trade/Device Name	Air Compression Therapy Device
510(K) number	K193354
Regulation Number	21 CFR 890.5650
Sponsor	Medella Health Limited
Trade/Device Name	FLOWpresso
510(K) number	K223729
Regulation Number	21 CFR 890.5650

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Table 6A: Summary of Comparison

	Subject Device	Predicate Device	Differences Discussion
Device name	Leg Massager (Models:RP-ALM070H,
RP-ALM071H)	Air Compression Therapy Device	N/A
510(k)
number	K232965	K193354	N/A
Manufacturer	Shenzhen Ruiyi Business Technology Co.,
Ltd.	Shenzhen Dongjilian Electronics
Co., Ltd.	N/A
Product
regulation	21 CFR 890.5650	21 CFR 890.5650	Same
Classification
name	Massager, Powered Inflatable Tube	Powered
Massager,
Inflatable
Tube	Same
Regulation
class	2	2	Same
Product code	IRP	IRP	Same
Indications for
use	Leg Massager (Models:RP-ALM070H,
RP-ALM071H) is intended for home to
temporarily relieve minor muscle
aches and/or pains, and to temporarily
increase circulation to the treated areas in
people who are in good health.	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 people who
are in good health. The Air
Compression Therapy Device
simulates kneading and stroking
of tissues by using an inflatable
garment.	Same
Rx or OTC	OTC	OTC	Same
Pressure range	0~240mmHg	0~240mmHg	Same
Inflation Time	3-30s	3-30s	Same
Deflation
Time	1-5s	1-5s	Same
Treatment
time	20 minutes	20 minutes	Same
Standard	ES 60601-1;
IEC60601-1-2;
ISO 10993-5:
ISO 10993-10;
IEC 60601-1-11	ES 60601-1;
IEC60601-1-2;
ISO 10993-5:
ISO 10993-10;
IEC 60601-1-11	Same
Mode of
compression	Sequential	Sequential/ Peristaltic	Same
Power source	100~240V 50/60Hz	100~240V 50/60Hz	Same
Power
consumption	24W	12W	Similar
Size and
appearance of	Thighs:	Leg:
sleeves (leg
part)	One size: 111624.9inch+8*33.5inch	One size: 73*26cm
Photo	Image: RP-ALM070H RP-ALM071H	Image	Similar
Housing
materials	Molded ABS enclosure	Molded ABS enclosure	Same
Number of
chambers	3	3	Same
Work mode	RP-ALM070H:
Six models (3 combine massage modes and
3 Separate Massage Modes)
C1: Massage full legs.
C2: Massage feet and calves.
(It can be used individually, and don't need	Mode 1:
Starting with the foot chamber
and progressing up the thigh
chamber, each section
compresses and the pressure
gradually rises to the	Although the subject device provides 6 kinds of
work mode, the Mode F1, F2, F3, M1, M2, M3 are
the similar with predicate device (K193354), while
the other work modes of subject device just have

to connect the air hose of thighs wraps.)
C3: Massage feet, calves, thighs by turn. It
will be turn off When you press the Button
C again.
T: Massages thighs
C: Massages calves
F : Massages feet. It will be turn off when
you press the Button S again.

RP-ALM071H:
Five models(3 combine massage modes and
2 Separate Massage Modes):
Combine 1: Massage feet and calves
Combine 2: Massage from calves to feet
Combine 3: Massage from feet to calves.
Press it again to turn off combine message
function.
F: Massage feet.
C: Massage calves. Press it again to turn off
separate massage function. | pre-determined air pressure level,
then decompresses and the
air pressure drops.
Once the thigh section
decompresses, the cycle begins
again.
Mode 1 follows this pressure
sequence:
Image: Diagram of pressure sequence

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 2 follows this pressure | same under different work modes, so the difference
of pressure range would not raise adversely impact
on safety and effectiveness. | |
| | | sequence: | |
| | | | |
| | | Mode 3:
include two stage, stage 1: it
work according to the method of
mode 1, after the stage 1 is
completed, it go 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.
Model1 Mode2
The pressure sequence of mode 3
combines mode 1 and mode 2 | |
| Safety feature | Button on display allows user to stop or
pause 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 |

7

8

9

10

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| Operating
environment | Temperature: 5°C-40°C,
Humidity: 15%-90% | Temperature: 5°C -40°C,
Humidity: 5%-90%
non-condensing | Same |
|----------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------|
| Transportation
and Storage
environment | Temperature: - 25°C70°C
Humidity:15%-90% non condensing
Atmospheric Pressure:75kPa-106kPa | Temperature: -20°C55°C;
Humidity: 5%-90% non
condensing
Atmospheric Pressure:75kPa-
106kPa | Similar |

Table 6B: Summary of Comparison

	Subject Device	Predicate Device	Differences Discussion
Device name	Leg Massager (Models:RP-ALM070H,
RP-ALM071H)	FLOWpresso	N/A
510(k) number	K232965	K223729	N/A
Manufacturer	Shenzhen Ruiyi Business Technology Co.,
Ltd.	Medella Health Ltd	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, IRT	IRP, IRT	Same
Indications
for Use	Leg Massager (Models:RP-ALM070H,
RP-ALM071H) is intended for home to
temporarily relieve minor muscle aches	The Flowpresso Device combines heat
and compression therapy.
Flowpresso is intended to treat post	Similar, although the predicate device is
intended to treat post traumatic and
post-surgical medical and/or surgical
	and/or pains, and to temporarily increase
circulation to the treated areas in people
who are in good health.	traumatic and post-surgical medical
and/or surgical conditions for which
localized thermal therapy are indicated.
Flowpresso is intended to be used by, or
on the order of, licensed health care
professionals based in rehabilitation
facilities, outpatient clinics and athletic
training settings.	conditions for which localized thermal
therapy are indicated, the subject device
is ,the working principles and expected
outcomes of the two are consistent. All of
them relieve pain by combining heat
therapy with air compression on the
affected area (subject device only covers
the thighs, calves, and feet, predictive
device also includes the back/hip), allowing
patients to relax.
Number of
patients that
can be treated
at one time	One	One	Same
Treatment
Time	20 minutes	01-40 minutes	Different, Although the “Treatment
Time” of the subject device is different
than the predicate devices, the treatment
time of the subject device is included in the
predicate device.
Heat Therapy	Not exceeding 45°C	Default: 86°F - 104°F	Similar, the maximum temperature of the
subject device is slightly higher than that of
the predicate device. The heating program
of the subject device can be selected to be
turned on or not, and all have passed IEC
testing. Small differences do not affect
safety and effectiveness.
Compression
Pressure
Levels	0〜240mmHg	5-130mm/Hg	Different, pressure range is dependent on
patient comfort levels and are adjusted in
real-time.
Static or
Intermittent
Pressure	Both	Both	Same
Power Down	Available	Available	Same
Heating
Mechanism	Thermotherapy	Thermotherapy	Same
User Interface	Touch Screen	Touch Screen	Same
Line voltage	100~240V	110-220V	Similar
Line
Frequency	50/60Hz	50/60 Hz	Same
Electrical
Safety
Standards	ES 60601-1;
IEC60601-1-2;
IEC 60601-1-11	ANSI/AAMI ES60601-
1:2005 + A1:2012
IEC 60601-1:2005 + A1:2012
EN60601-1:2006 +A1:2013	Similar
Operating
Temperature	5°C- 40°C	60°F - 80°F (16°C - 27°C)	Different, Although the "Operating
Temperature"
of the subject device is
different than the predicate devices, they
comply with ANSI/AAMI ES60601-1, so
the difference does not affect the safety and
effectiveness.
Storage
Temperature	- 25°C~70°C	33°F - 122°F (1°C - 50°C)	Different, Although the "Storage
Temperature"
of the subject device is
different than the predicate devices, they
comply with ANSI/AAMI ES60601-1, so
Operating
Humidity	15%-90%	Below 60% Noncondensing	the difference does not affect the safety and
effectiveness.
Different, Although the "Operating
Humidity" of the subject device is different
than the predicate devices, they comply
with ANSI/AAMI ES60601-1, so the
difference does not affect the safety and
effectiveness.
Storage
Humidity	15%-90%	Below 60% Noncondensing	Different, Although the "Storage
Humidity" of the subject device is different
than the predicate devices, they comply
with ANSI/AAMI ES60601-1, so the
difference does not affect the safety and
effectiveness.
Operating
Atmospheric
Pressure and
Altitude	75kPa-106kPa	700 hPa – 1060 hPa
(corresponds to a max. elevation
of 9,842 ft. 6 in (3000m))	Similar
Types of
Garments	Sleeves for thighs, calves, and feet	Various anatomical
thermal/compression garments
for: Back/Hip, arm, leg, feet	Different, the type of garments of the
predicate device exceeds that of the subject
device, which does not include the back/ip
part. So the risk of subject device is smaller
than that of predicate device.
Patient
Contacting
Material	All encompassed with a Nylon with a
Polyurethane laminate material.	Needle cotton, non-conductive
and non-woven lining. All
encompassed with a PVC
material.	Different, Although the material of the
subject device is different than the predicate
devices, they comply with ISO10993-5 and
ISO10993-10, so the difference does not
			affect the safety and effectiveness.
Multi-Patient
Use and Single
Patient Use
Wraps	Multi-Patient Use	Multi-Patient Use	Same
Biocompatibility	Cytotoxicity testing per ISO
10993-5
Sensitization testing per ISO
10993-10
Irritation testing per
ISO 10993-10	Cytotoxicity testing per ISO
10993-5
Sensitization testing per ISO
10993-10
Irritation testing per
ISO 10993-10	Same
Sterile/Non
Sterile	Non-sterile only	Non-sterile only	Same
Cleaning
Disinfection
Validation of
Labeling	Yes- for Multi-Patient use
reusable wraps	Yes- for Multi-Patient use
reusable wraps	Same
Human Factors
testing to
confirm
intended users
have found
instructions for
cleaning and
disinfection
easy to use	Yes- for Multi-Patient use
reusable wraps	Yes- for Multi-Patient use
reusable wraps	Same
Expected Life of	Based on frequency of use and	Based on frequency of use and	Same
Garments	continued functional
performance	continued functional
performance
Validation of
repeated
cleaning and
disinfection for
reusable
garments	Yes- for Multi-Patient use
reusable wraps	Yes- for Multi-Patient use
reusable wraps	Same

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Summarv 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 1-11: 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 Compatibility ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC TS 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization

Conclusion

Based on the indications for use, technological characteristics, and non-clinical performance data, "Leg Massager (Models:RP-ALM070H, RP-ALM071H)" is as safe, as effective, and performs as well as the legally marketed predicate devices. Therefore, the subject device is substantially equivalent to the predicate device.