(134 days)
Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Air compression therapy system FO3002 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 compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin.
This document is a 510(k) Premarket Notification from the FDA for an "Air compression therapy system FO3002". It demonstrates the device's substantial equivalence to a legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608).
Based on the provided text, the device does not involve an AI algorithm or performance criteria that would require a study as described in the prompt. The "acceptance criteria" discussed are related to technical specifications and safety standards, rather than diagnostic accuracy or human performance with AI assistance.
Therefore, many of the requested sections (2-9) are not applicable to this document as it pertains to a physical medical device (an air compression therapy system) that does not incorporate AI or require assessment of its diagnostic performance through a test set and ground truth.
However, I can extract the acceptance criteria in terms of the device's characteristics and how it compares to the predicate, which serves as its "performance" in the context of this 510(k) submission.
1. A table of acceptance criteria and the reported device performance
In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This is primarily shown through a comparison of technological characteristics and indications for use. The "reported device performance" in this context refers to how closely the subject device's characteristics match or are explained in relation to the predicate.
| Feature/Criteria | Acceptance Criteria (Predicate: NormaTec Pulse/Pulse Pro, K160608) | Reported Device Performance (Air compression therapy system FO3002) | Discussion/Equivalence |
|---|---|---|---|
| Indications for Use | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Same |
| Pressure Range | 30-110mmHg | 30-110mmHg | Same |
| Treatment Time | 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. | 10-60min | Similar (Subject device's range is smaller, which does not raise adverse impact on safety/effectiveness). |
| Standard Compliance | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, ISO 10993-5, ISO 10993-10 | Similar (Subject device tested to more standards, indicating robust compliance). |
| Mode of Compression | Sequential Gradient, Peristaltic and Pulsing | Sequential (The document lists various modes for the subject device: Normal, Sequential, Double, Whole, Combined A+B, which are compared to the predicate's modes, stating A and C are the same with the predicate). | Same (with additional modes or variations whose differences don't adversely impact safety/effectiveness). |
| Power Source | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | Adaptor: AC 100-240V, 50/60Hz; Main unit: DC 15V, 1.5A | Similar |
| Power Consumption | 14W | 22.5VA | Similar |
| Dimensions (Main unit) | 4" x 5" x 9" | 265 x 130 x 100mm | Similar |
| Housing Materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of Chambers (Sleeves) | 5 or less | 6 | Similar (The additional chamber is likely an enhancement not impacting fundamental safety/effectiveness for the stated indications). |
| Safety Features | 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 |
| Intended Population/Environment | Not explicitly stated in comparison table but implied OTC/Home use. | Intended for home use. Over-The-Counter Use. | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is Not Applicable (N/A). The device is an air compression therapy system, not an AI/software device that processes data for diagnostic purposes requiring a test set for performance evaluation. The submission relies on technical and safety testing to demonstrate equivalence, not clinical performance data from a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. No diagnostic "ground truth" or expert review of patient data was necessary for this device type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set or adjudication process as described for AI/diagnostic devices was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No ground truth of this nature was established. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device, against which the subject device's technical specifications and safety profile are compared for substantial equivalence.
8. The sample size for the training set
N/A. No training set was used as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
N/A. No training set or associated ground truth was established.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the "acceptance criteria" (i.e., is substantially equivalent to a legally marketed predicate) is presented as a comparative analysis of technical specifications and safety standards compliance.
- Evidence Type: The submission relies on non-clinical performance testing (compliance with electrical safety, EMC, biocompatibility standards like IEC 60601-1-11, IEC 60601-1-2, ANSI AAMI ES60601-1, ISO 10993-5, ISO 10993-10, IEC 62133-2) and a direct comparison of the subject device's features to those of the predicate device.
- Methodology: The manufacturer states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This indicates that no human or animal studies were conducted to prove performance for this 510(k) submission. Instead, the demonstration of substantial equivalence is built upon:
- Identical Indications for Use.
- Similar (or identical) technological characteristics: as detailed in the comparison table (e.g., pressure range, mode of compression, power source, materials, safety features). Any differences are argued not to raise new questions of safety or effectiveness.
- Compliance with recognized electrical safety and biocompatibility standards.
- Conclusion of the Study (FDA's Determination): The FDA's letter (K212169) signifies that based on the provided information, the device is considered "substantially equivalent" to predicate devices, meaning it is "as safe, as effective, and performs as well as the legally marketed predicate devices." This substantial equivalence is the ultimate "proof" required for market clearance under the 510(k) pathway for this type of device.
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November 23, 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 Cn
Re: K212169
Trade/Device Name: Air compression therapy system FO3002 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: October 18, 2021 Received: October 18, 2021
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.
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
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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,
For 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) K212169
Device Name Air compression therapy system FO3002
Indications for Use (Describe)
Air compression therapy system FO3002 is intended for home 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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K212169
Traditional
May 31, 2021
Type of Submission
Date Prepared
Submission Sponsor
Manufacturer Name Address
Tel Email Contact Person
Device Identification
- Trade Name Regulation Number Regulation Name Device Classification Product Code Panel Previous Submissions
Application Correspondent
Company Name Address
Tel Email Contact Person
Indications for Use
FOSHAN HONGFENG CO., LTD. No.4-2 Leqiang Road, Leping Sanshui, Foshan, Guangdong, China 86-0757-8392028 573619164@qq.com Dongfeng Cheng
Air compression therapy system FO3002 21 CFR 890.5650 Power inflatable tube massager Class II IRP Physical Medicine None
Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China 86-15626132181 sam(@spicagloble.com Sam Lin
Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Device Descrintion
Air compression therapy system FO3002 is consist of air pressure sensor, air pump, sleeves etc
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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 compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin.
Predicate and Reference Device Information
| Sponsor | NormaTec Industries, LP |
|---|---|
| Trade/Device Name | NormaTec Pulse and NormaTec Pulse Pro |
| 510(K) number | K160608 |
| Regulation Number | 21 CFR 890.5650 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device name | Air compression therapy system FO3002 | NormaTec Pulse and NormaTec Pulse Pro | N/A |
| 510(k) number | K212169 | 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 | Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the 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 | 10-60min | Stays on until the user turns it off or can be set up to turn off in a range of 10 mins to | SimilarThe treatment time of subject device is smaller than predicate |
| continuous / User controlled 10 minutes to 175 minutes or continuous -total time over 4 segments. | device (K160608), so the difference of treatment time would not raise adversely impact on safety and effectiveness. | ||
| Standard | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2, IEC 60601-1-11 , IEC 62133-2, ISO 10993-5, ISO 10993-10 | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Similar |
| Mode of compression | Sequential | Sequential Gradient, Peristaltic and Pulsing | Same |
| Power source | Adaptor: AC 100-240V, 50/60HzMain unit: DC 15V, 1.5A | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | Similar |
| Power consumption | 22.5VA | 14W | Similar |
| Dimensions (WHD) | 265 x 130 x 100mm | 4" x 5" x 9" | Similar |
| Photo | Image: a white remote control with several buttons | N/A | N/A |
| Size and appearance of sleeves (leg part) | Image: a black leg sleeve | Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60" | Similar |
Table 6A: Summary of Comparison
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| 510(K) Summary | |
|---|---|
| -- | ---------------- |
| XL: 110 x 70cmXXXL: 125 x 76cm | |||
|---|---|---|---|
| Housingmaterials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number ofchambers | 6 | 5 or less | Similar |
| A Normal Mode: Chamber ① inflates to pressure set value withinmaximum 12 seconds. If the chamber pressure reaches presetvalue within 12 seconds, holding pressure on for the rest of theperiod then shift to next chamber inflating. If the chamberpressure doesn't reach pressure preset value within the first 12seconds, inflation is extended for additional maximum 10seconds. Within this 10-second period, if the chamber pressurereaches the preset value, then shift to next chamber inflating. Ifthe chamber pressure cannot reach the preset value at the end ofadditional 10 seconds, then shift to next chamber inflatingautomatically. 3 seconds after the next chamber (for exampleChamber ②) inflating, the inflated chamber (for exampleChamber ①) deflates. Chamber ② works like Chamber ①.Chamber ③, ④, ⑤, ⑥ repeats the similar procedure as Chamber②, ③, ④, ⑤.B Sequential Mode: Chamber ① inflates to pressure set valuewithin maximum 12 seconds. If the chamber pressure reachespreset value within the 12 seconds, holding pressure on them shiftto next chamber inflating. If the chamber pressure doesn't reachpressure preset value within the first 12 seconds, inflation isextended for additional maximum 10 seconds. Within this | Sequential mode:Starting with the distal chamberand progressing up the proximalchamber, each sectioncompresses and the pressuregradually rises to thepre-determined air pressurelevel, then decompresses andthe air pressure drops.Once the top sectiondecompresses, the cycle beginsagain. again.Normatec Pulse mode:Starting with the distal zone andprogressing up the proximalzone, one zone compresses andthe pressure gradually rises tothe pre-determined air pressurelevel, holds the air of previoustwo zone, the other zones do nothold, until the last zone | Although the subject deviceprovides 5 kinds of work mode,the Mode A and Mode C are thesame with predicate device(K160608), while the otherwork modes of subject devicejust have difference aboutinflatable order of the differentchambers. The treatmentpressure range are the sameunder different work modes, sothe difference of pressure rangewould not raise adverselyimpact on safety andeffectiveness. | |
| Work mode |
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| 10-second period, if the chamber pressure reaches the presetvalue, holding pressure on then shift to next chamber inflating. Ifthe chamber pressure cannot reach the preset value at the end ofadditional 10 seconds, holding pressure on then shift to nextchamber inflating automatically. Chamber ② works like Chamber①. Chamber ③, ④, ⑤, ⑥ repeats the similar procedure asChamber 2, 3, 4 ⑤. After the last Chamber ⑥ completedinflation, Chamber ①, ②, ③, ④, ⑤, ⑥ operation cycle starts 13seconds after deflation begins. | finished, deflate the all lastthree zone then enter into nextcycle. |
|---|---|
| C Double Mode: Chamber ① ② as a group inflatessynchronously to pressure set value within maximum 24 seconds.If the grouped chamber pressure reaches preset value within the24 seconds, holding pressure on for the rest of the period thenshift to next group (③ ④) inflating. If the grouped chamberpressure doesn't reach pressure preset value within the first 24seconds, inflation is extended for additional maximum 20seconds. Within this 20-second period, if the Chamber ① ②pressure reaches the preset value, then shift to next group (34)inflating. If the Chamber ① ② pressure cannot reach the presetvalue at the end of additional 20 seconds, then shift to next group(34) inflating automatically. 3 seconds after the next group(Chamber ③ ④) inflating, the inflated group (Chamber ① ②deflates. Chamber group ③ ④⑤⑥ works like Group ① ②.Start next Chamber (① ②)-(③ ④)-(⑤ ⑥) operation cycle 13seconds after Chamber group ⑤ ⑥ begins deflation. | |
| D Whole Mode: Chamber 1, 2, 3, 4, 5, 6 inflatessynchronously to pressure set value within maximum 72 seconds. |
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| If the chamber pressure reaches preset value within the 72seconds, holding pressure on for the rest of the period, thendeflates synchronously. If the chamber pressure doesn't reachpressure preset value within the first 72 seconds, inflation isextended for additional maximum 36 seconds. Within this 36-second period, if the chamber pressure reaches the preset value,then deflates synchronously. If the chamber pressure cannotreaches the preset value at the end of additional 36 seconds, thenChamber (1), (2), (3), (4), (5), (6) deflates automatically. Repeat theChamber (1), (2), (3), (4), (5), (6) operation cycle 13 seconds afterChamber (1), (2), (3), (4), (5), (6) deflation begins.E Combined A mode + B mode: Normal Mode followed bySequential ModeImage: Modes of operation | |||
|---|---|---|---|
| Safety feature | Button on display allows user to stop or pause therapy session atany time | Button on display allows user tostop or pause therapy session atany time | Same |
| Technology | Compressor and valve system which sequentially inflatesinflatable chambers | Compressor and valve system which sequentially inflates | Same |
| inflatable chambers |
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Performance Characteristic
The device meets all the applicable technical requirements of :
IEC 60601-1-11: 2015 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2: 2014 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAM ES60601-1:2005/(R)2012 and A1:2012, C1:2009/R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 IEC 62133-2: 2017 - Secondary cells and batteries containing alkaline or other nor-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Conclusion
Based on the indications for use, technological characteristical performance data, "Air compression therapy system FO3002 (K number)" is as safe, as effective, and performs as well as the legally market predicate devices, "NormaTec Pulse Pro (K160608)". Therefore, the subject device is substantially equivalent to the predicate device.
§ 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).