(122 days)
Not Found
No
The description mentions a microprocessor and software controlling timing and pressure based on a sensor, which is standard automated control, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The intended use explicitly states its purpose is for "temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas," which are therapeutic benefits.
No
The device is indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, which are therapeutic rather than diagnostic purposes. It simulates kneading and stroking of tissues and functions as a massager.
No
The device description explicitly lists hardware components such as an air pump, air pressure sensor, leg sleeves, adapter, and a control unit with a plastic case. While software controls the operation, it is integral to a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of muscle aches and pains and temporary increase in circulation. This is a therapeutic/physical therapy application, not a diagnostic one.
- Device Description: The device is a physical therapy device that applies external pressure to the limbs. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device performing any tests or measurements on biological samples to provide diagnostic information.
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
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. 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 leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
Environment of use of the device: Clinics, hospital, athlete training, and home environments
Principle of operation:
The control unit is connected to the leg sleeves via hose. The control unit contains an air pump, pressing "Power" button to begin normal treatment status, the air pump will pump air into leg sleeves with stetted rhythm though air pipe, the sleeve fits on the low limbs and provide therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Low limbs (Foot, calf and upper leg)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments
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)
There was no clinical testing performed.
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): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 contains 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.
March 31, 2022
Shenzhen Future Electronic Co., Ltd % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213745
Trade/Device Name: Air Compression Therapy Device, model: ST-502 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 2, 2022 Received: February 2, 2022
Dear You Yijie:
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.
1
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 medical devices and radiation-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.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Air Compression Therapy Device, model: ST-502
Indications for Use (Describe)
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
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
510(k) Summary — K213745
1. Submitter's Information
Establishment Registration Information
Name: SHENZHEN FUTURE ELECTRONIC CO., LTD. Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116
Contact Person of applicant
Name: Zhang Benrong Address: Room 301-302, No.15 HanchengRoad, Qingdao Free Trade Zone, Shandong, China, 266555 TEL: +86-13410947296 Email: zhaoqihong@futuresz.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Nov. 15, 2021
2. Device Information
| Trade Name: | Air Compression Therapy Device |
|---|---|
| Model: | ST-502 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |
3. Predicate Device Information
Predicate device:
510(k) submitter/holder: Shenzhen Dongjilian Electronics Co., Ltd.
4
| 510(K) Number: | K193354 |
|---|---|
| Trade Name: | Air Compression Therapy Device |
| Model: | S9019 |
| Classification name: | Massager, Powered Inflatable Tube |
| Review panel: | Physical Medicine |
| Product code: | IRP |
| Regulation Class: | II |
| Regulation Number: | 21CFR890.5650 |
4. Device description
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. 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 leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
Environment of use of the device: Clinics, hospital, athlete training, and home environments
Principle of operation:
The control unit is connected to the leg sleeves via hose. The control unit contains an air pump, pressing "Power" button to begin normal treatment status, the air pump will pump air into leg sleeves with stetted rhythm though air pipe, the sleeve fits on the low limbs and provide therapy.
5. Indications for Use
The Air Compression Therapy Device (model: ST-502) is indicated for the temporary relief of minor
5
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 (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
6. Summary of technological characteristics of device compared to the
| SE
Comparisons | Subject device
(Air Compression Therapy
Device,
model: ST-502) | Primary predicate device
(Shenzhen Dongjilian
Electronics Co.,Ltd.
Air Compression Therapy Device,
Model: S9019) | Discussion of
difference | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510K Number | K213745 | K193354 | / | |
| Classification | 21 CFR890.5650 | 21 CFR890.5650 | Same | |
| Product Code | IRP | IRP | Same | |
| FDA Class | II | II | Same | |
| Indications for Use | The Air Compression Therapy
Device (model: ST-502) 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
(model: ST-502) simulates kneading
and stroking of tissues by using an
inflatable garment. | 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 | |
| Over-The-Counter
Use | Yes | Yes | Same | |
| Model | ST-502 | S9019 | / | |
| Treatment
area/Structure of
Sleeves | Low limbs (Foot, calf and upper leg) | Low limbs (Foot, calf and upper leg) | Same | |
| Environment of Use | Clinics, hospital, athlete training,
and home environments | Clinics, hospital, athlete training,
and home environments | Same | |
| Patient Population | Adult | Adult | Same | |
| Power source | 100-240V, 50-60Hz | 100-240V 50/60Hz | Same | |
| Power Consumption | 12w | 12W | Same | |
| SW/Firmware/
Microprocessor
Control | Microprocessor | Microprocessor | Same | |
| Therapy Time | 20 mins | 20 minutes | Same | |
| Output pressure
range | 0240 mmHg | 0240 mmHg | Same | |
| Air pressure Level
/Compression levels | 3 levels settings:
low level:150mmHg;
Medium level:185mmHg;
High Level: 215mmHg | 3 levels settings:
low level:150mmHg;
Mid level:185mmHg;
High Level: 215mmHg | Same | |
| Pressure error
range | $\pm$ 25mmHg | $\pm$ 25mmHg | Same | |
| Inflation time | 3-30s | 3-30s | Same | |
| Keep time | 1-5s | 1-5s | Same | |
| Deflation time | 1-5s | 1-5s | Same | |
| Mode types | Sequential/ Peristaltic | Sequential/ Peristaltic | Same | |
| Cycle time | 25 seconds to 3 minutes and 40
seconds | Range of 25 sec to 3 min 40 sec | Same | |
| Number of
chambers | 3 Chambers | 3 Chambers | Same | |
| Number of
treatment mode | 3 modes | 3 modes | Same | |
| Modes (visual
description) | M1:
Start in the foot room and push
up the thighs, the pressure
gradually rises to a
predetermined pressure level
with each compression, then
depressurizes and the pressure
drops. Once the thighs are
decompressed, the circulation
begins again.
Pattern 1 follow this stress
sequence:
Image: Pattern 1 stress sequence
M2:
Starting in the foot chamber,
push up the thighs, and with
each compression, the pressure
gradually rises to a
predetermined air pressure level,
holding the air until the entire
garment is compressed. All three
parts decompress | Mode 1:
Starting with the foot chamber and
progressing up the thigh 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 thigh section
decompresses, the cycle begins
again.
Mode 1 follows this pressure
sequence:
Image: Mode 1 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 | Same | |
| | | | | |
| | | simultaneously, air pressure
drops, and the circulation begins
again.
Pattern 2 follow this pressure
sequence:
Image: Pressure sequence diagram | decompress simultaneously and the
air pressure drops, then cycle begins
again.
Mode 2 follows this pressure
sequence
Image: Pressure sequence diagram | |
| | | M3: It consists of two phase.
Phase 1: It works as a pattern 1
method, and after phase 1 is
completed, it continues to phase 2
(working as a pattern 2 method)
until phase 2 is completed, and
then continues to the next cycle
without interruption.
The pressure sequence of mode 3
is combined with mode 1 and mode
2. | Mode 3:
include two stage, stage 1: it works
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 .
Mode1 $\rightleftharpoons$ Mode2
The pressure sequence of mode 3
combines mode 1 and mode 2. | |
| Noise level | $\leq$ 65db | | $\leq$ 65dB | Same |
| Sleeve Material | Material of memory cloth: 100%
polyester
material Velcro(loops):
nylon70%, polyester 30%
Velcro (hooks): 100% nylon | | Nylon with a Polyurethane laminate | Different
(Discussion is
indicated in D1) |
| Housing Materials | Molded ABS enclosure | | Molded ABS enclosure | Same |
| Patient contact | Non-conductive attachments | | Non-conductive attachments | Same |
| Size and
appearance | L215W65H51mm | | 10.2x5.9×25.6
(in ) | Different
(Discussion is
indicated in D2) |
| | | | | |
| Weight | 1400g (approximately:3.08 pounds)
(machine+right/left wrap)
1600g (approximately:3.52 pounds)
(main unit+ leg sleeves +adapter)
Image: white device | 4.6 pounds
Image: black device | Different
(Discussion is
indicated in D3) | |
| Size and
appearance of
sleeves (leg part) | Leg: One size: L720W270mm
Image: leg sleeve | Leg: One size : 7326cm
Image: leg sleeves | Similar
(Discussion is
indicated in D4) | |
| Safety Features | The “Power” button allows user to
stop therapy session at any time | Standby button allows user to stop
therapy session at any time | Similar
(Discussion is
indicated in D5) | |
| Operating
environment | Temperature: 5°C40°C55°C
Humidity:15%-93%, non-
condensing
Atmospheric pressure: 70kPa-
106kPa | Temperature: 5°C-40°C,
Humidity:5%-90% no-condensing | Similar
(Discussion is
indicated in D6) | |
| Transportation &
Storage
environment | Temperature:-20°C
Humidity:5%-90%, non-condensing
Atmospheric pressure: 75kPa-
106kPa | Temperature: -20°C~55°C;
Humidity:5%-90% noncondensing
Atmospheric Pressure:75kPa-
106kPa | Same | |
| Standards | ANSI AAMI ES60601-
1:20051/(R)2012 and A1:2012, | ES 60601-1;
IEC60601-1-2;
ISO 10993-5: | Same | |
| C1:20091(R)2012
A2:2010(R)2012
IEC 60601-1-2 Edition 4.0 2014;
ANSI AAMI HA 60601-1-11:2015
ISO 10993-5 Third edition 2009-06-01:
ISO 10993-10 Third Edition 2010-08-01; | and | ISO 10993-10;
IEC 60601-1-11 | | |
predicate devices (K193354)
6
7
8
9
The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The subject device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10 with positive results, the material difference of subject device with predicate device S9019 (K193354) do not raise new questions of safety and effectiveness.
- D2: The dimensions between subject device and predicate device S9019 (K193354) are the difference, but the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2. so the differences do not affect the safety and effectiveness so the difference will not affect the safety and effectiveness.
- D3: The weight of subject device is difference with predicate device S9019 (K193354) but the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1 and IEC 60601-1-2, so the difference will not affect the safety and effectiveness.
- D4: The size of sleeves (leg part)" of subject device is similar with the predicate device S9019 (K193354). The treatment effect of the Air Compression Therapy Device depends on the treatment pressure, treatment time, chamber number and treatment site, and the subject device and predicate device S9019 (K193354) are the same with treatment pressure, treatment time, chamber number and treatment site. So the difference will not affect the safety and effectiveness.
- D5: Just the name of button is difference, the subject device can be stopped therapy session at any time through the "Power" button by user. This difference betweet subject device predicate device S9019 (K193354) will not affect the safety and effectiveness.
- D6: Humidity of transportation & storage of subject device is similar with predicate device S9019 (K193354). But the subject device and predicate device S9019 (K193354) are both complied with ANSI/AAMI ES60601-1-11, so the differences do not affect the safety and effectiveness so the difference will not affect the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, ANSI AAMI HA 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993-5 and ISO 10993-10 for biological compatibility and IEC 62304 for software verification are complied. See below table for details:10993-1
10
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements |
| For Basic Safety And Essential Performance | |
| IEC 60601-1-2 Edition 4.0 | |
| 2014 | Medical Electrical Equipment -- Part 1-2: General Requirements |
| For Basic Safety And Essential Performance -- Collateral | |
| Standard: Electromagnetic Disturbances -- Requirements And | |
| Tests | |
| ANSI AAMI HA 60601-1-11: | |
| 2015 | Medical Electrical Equipment - Part 1-2: General Requirements |
| for Basic Safety And Essential Performance - Collateral | |
| Standard: Electromagnetic Disturbances - Requirements And | |
| Tests | |
| ISO 10993-5 Third edition | |
| 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in |
| vitro cytotoxicity | |
| ISO 10993-10 Third Edition | |
| 2010-08-01 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization | |
| ISO 10993-1 Fifth edition | |
| 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and |
| testing within a risk management process | |
| IEC 62304 Edition 1.1 2015- | |
| 06 CONSOLIDATED | |
| VERSION | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005.
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Air Compression Therapy Device, model ST-502 is substantially equivalent to the predicate devices.