(157 days)
Not Found
No
The description focuses on mechanical compression and user-controlled settings, with no mention of AI/ML terms or functionalities.
Yes.
The device is intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas, which are therapeutic claims.
No
The device is intended to temporarily relieve minor muscle aches and/or pains and increase circulation, which are therapeutic functions, not diagnostic ones. It does not identify or detect disease.
No
The device description explicitly details hardware components such as a pump, inflatable sleeve, hose, hand controller, power supply, and battery. It also mentions testing against hardware-related standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133-2).
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 Air Pressure Foot Massager works by applying external physical pressure to the feet to temporarily relieve muscle aches and increase circulation. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for temporary relief of muscle aches and increasing circulation, not for diagnostic purposes.
The device description and intended use are consistent with a physical therapy or massage device, not an IVD.
N/A
Intended Use / Indications for Use
Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process.
The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
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
Over-The-Counter Use
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI ES60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance (IEC 60601-1);
- 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 A safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
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.
February 19, 2022
Xiamen Simo Electronic Co., Ltd % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD. FangShan District Beijing, Beijing 102401 China
Re: K212935
Trade/Device Name: Air Pressure Foot Massager Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 24, 2021 Received: December 27, 2021
Dear Ray Wang:
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
Indications for Use
510(k) Number (if known) K212935
Device Name Air Pressure Foot Massager
Indications for Use (Describe)
Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to 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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3
510(k) Summary
The assigned 510(k) Number: K212935
-
- Date of Preparation
02/05/2022
- Date of Preparation
-
Sponsor 2.
XIAMEN SIMO ELECTRONIC CO., LTD
Floor 3rd-5th, No.173 Siming Park, Tong'an Industrial Zone, Tong'an District, Xiamen City, Fujian Province, China, 361100 Contact Person: Wang Qinsheng Position: General Manager Tel: +86-13860109615 Fax: +86-592-5917070 Email: jeson@xmsimo.com
-
- Submission Correspondent
Contact Person:
- Submission Correspondent
Mr. Ray Wang Tel: +86-18910677558 Fax: +86-10-52214696 Email: information(@believe-med.com
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401
4
4. Identification of Proposed Device
Trade Name: Air Pressure Foot Massager Common Name: Physical Medicine Model(s): SM-512F
Regulatory Information: Classification Name: Massager, Powered Inflatable Tube Classification: II; Product Code: IRP; Regulation Number: 21 CFR 890.5650; Review Panel: Physical Medicine.
Indication for Use:
Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
-
- Device Description
Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process.
- Device Description
The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.
The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
-
Identification of Predicate Device 6.
Predicate Device 510(k) Number: K201935 Product Name: Air Pressure Therapy System Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd. -
- Non-Clinical Test Conclusion
5
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
AAMI ES60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance (IEC 60601-1);
-
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 A safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
-
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
-
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 9.
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device (K201935) | Remark |
|---|---|---|---|
| Product Code | IRP | IRP | SAME |
| Regulation No. | 21 CFR 890.5650 | 21 CFR 890.5650 | SAME |
| Class | II | II | SAME |
| Indication For Use | Air Pressure Foot Massager is intended to | ||
| temporarily relieve minor muscle aches | |||
| and/or pains, and to temporarily increase | |||
| circulation to the treated areas. | Air Pressure Therapy System VU-IPC04B | ||
| is 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 |
| Technology | Compressor and valve system which | ||
| sequentially inflates inflatable chambers. | Compressor and valve system which | ||
| sequentially inflates inflatable chambers. | SAME | ||
| ITEM | Proposed Device | Predicate Device (K201935) | Remark |
| Pressure range | 30-110mmHg | 30-110mmHg | SAME |
| Treatment time | 0-30min, default as 15min | 5-99mins | Analysis 1 |
| Mode of compression | Sequential | Sequential | SAME |
| Power source | Voltage: DC5V 1A | AC 110-240V; 50Hz/60Hz | Analysis 2 |
| Lithium Battery: 3.7V, 2400mah (Battery | |||
| meet IEC 62133-2) | Battery meet IEC 62133-2 | ||
| Power consumption | 5W | 35W | Analysis 2 |
| Number of chambers | 4pcs/Pair | 6 | Analysis 3 |
| Size of the sleeves | 340365360mm | M: 91x65cm, XL: 110x70cm(overlapping) | |
| XXL: 125x76cm(overlapping) | Analysis 4 | ||
| Dimension | 2115550mm | 22014090mm | Analysis 4 |
| Weight | $1.15\pm0.1$ kg | 1.6Kg | Analysis 4 |
| Work mode | Mode 1 | Mode A: | Analysis 5 |
| The model is divided into two processes, | In this mode, only a single chamber is inflated at a | ||
| the first process includes inflating, | |||
| deflating and holding pressure. The | time. Starting from the chamber (1) and working up to | ||
| the chamber (6). Then the cycle repeats. | |||
| inflating sequence of air chambers of | |||
| sleeves is: | Mode B: | ||
| The chamber No.(1) Inflate and keep | |||
| pressure three times, deflated, Then the | In this mode, the chamber (1) stays inflated. It | ||
| gradually adds a chamber until all six chambers are | |||
| filled with air. Then the cycle repeats. | |||
| chamber No (2) inflate and keep | |||
| pressure three times, deflated. | Mode C: | ||
| In the second process, the air pump is | |||
| always opened, and the air is inflated | In this mode, chamber (1) inflates & deflates 4 times, | ||
| then holds pressure; next chamber (2) inflates & | |||
| deflates 4 times, chamber (1)(2) hold pressure; | |||
| and deflated according to the following | |||
| inflating sequence: | chamber (3) inflates & deflates 4 times, chamber (2)(3) | ||
| hold pressure, chamber (1) deflates; chamber (4) | |||
| (1)(2)-(1)-(2)-(1)(2)-(1)-(2) | |||
| -(1)(2)-(1)-(2)-(1)(2)-(1)-(2)-(2)-(1) | inflates & deflates 4 times, chamber (3)(4) hold | ||
| pressure, chamber (2) deflates; working as this way up | |||
| to chamber (6). Then the cycle repeats. | |||
| The inflating time is different according | |||
| to the intensity selected. | Note: Under this mode, for the FIRST CYCLE, it | ||
| works as mode B to warm up; from the 2nd cycle on, | |||
| it works as PULSE Mode C. | |||
| Mode 2 | Mode D: | ||
| In this model, at first ,the chamber No. | |||
| (1) inflate and keep pressure four times, | In this mode, all chambers inflates together, and | ||
| deflates together. Then the cycle repeats | |||
| then chamber No. (1)(2)are inflated and | |||
| deflated at the same time. | |||
| Mode 3 | |||
| The chamber No. (1)(2) are inflated and | |||
| deflated at the same time, Then the cycle | |||
| repeats. | |||
| Item | Proposed Device | Predicate Device | Remark |
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with IEC 60601-1,IEC | ||
| 60601-1-11 | Comply with IEC 60601-1,IEC | ||
| 60601-1-11 | SAME | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Battery Safety | Comply with IEC 62133-2 | Comply with IEC 62133-2 | SAME |
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | Terylene | Not Publicly Available | Analysis |
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | SAME |
| Sensitization | Comply with ISO 10993-10 | Comply with ISO 10993-10 | SAME |
| Irritation | Comply with ISO 10993-10 | Comply with ISO 10993-10 | SAME |
6
7
Analysis 1
Although the treatment time range of subject device is 0 to 30mins, which seems to be smaller than the predicate devices, the default value is 15min which is suitable for daily use. In the process of use, the user can start or stop at any time by the power button on the hand controller, so the difference of Treatment time would not raise adversely impact on safety and effectiveness.
Analysis 2
Although the subject device design and specification parameter between the predicate devices, they are both complied with IEC60601-1, so the minor differences of power source and Power consumption does not raise any new issue of the safety or effectiveness.
Analysis 3
Number of chambers is different, but the application site and treatment pressure range are the same. The minor difference of number of chambers does not raise any new issue of the safety or effectiveness.
Analysis 4
The proposed device is different in appearance, dimension and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.
Analysis 5
Although the work mode is different, while the difference of work modes just because the inflatable order of the different chambers. The treatment pressure range is the same under different work modes, so the difference of work mode would not raise adversely impact on safety and effectiveness.
Table 3 Safety Comparison
Analysis
8
Although the materials in contact with human skin are different, they all meet the requirements of ISO 10993-5/10 and will not affect product safety.
10. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Air Pressure Foot Massager (SM-512F) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K201935.