(251 days)
Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.
Air Pressure Therapy System is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.
The provided FDA 510(k) summary (K201982) indicates that the Air compression therapy system FO-3001 and FO-3008 are substantially equivalent to the NormaTec Pulse and NormaTec Pulse Pro (K160608) predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantified list with pass/fail thresholds. Instead, the substantial equivalence is established by comparing the subject device's characteristics against those of the predicate device (K160608). The underlying assumption is that if the subject device's performance, safety features, technological characteristics, and intended use are similar or equivalent to a legally marketed predicate, it meets the necessary criteria for market clearance.
The "acceptance criteria" are implicitly derived from the characteristics of the predicate device and the recognized consensus standards. The "reported device performance" is then the subject device's characteristics as described.
| Characteristic | Acceptance Criteria (Predicate Device K160608) | Reported Device Performance (FO-3001/FO-3008) | Discussion of Differences |
|---|---|---|---|
| Indications for Use | Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in treated areas. | Same |
| Rx or OTC | OTC | OTC | 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. | 1-60mins | Similar: Subject device's treatment time is smaller. Concluded not to adversely impact safety and effectiveness. |
| Standards Applied | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 60601-1-11:2015, IEC 60601-1-2:2014, IEC 60601-1:2005, ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-12:2012 | Similar: Both devices adhere to relevant electrical safety, EMC, and biological evaluation standards. The subject device lists additional ISO standards for biological evaluation. |
| Mode of Compression | Sequential Gradient, Peristaltic and Pulsing | Sequential (FO-3001 has 6 modes including "Normal Mode" which is sequential; FO-3008 has 4 modes including "Normal Mode" which is sequential) | Same (regarding sequential): While the subject device offers more "work modes" (e.g., Double Wave, Whole Squeeze, Combined modes), the "Mode A (Normal Mode)" for both FO-3001 and FO-3008 aligns with the predicate's sequential compression. The differences in other modes and chamber inflation order are argued not to adversely impact safety and effectiveness due to the same pressure range. |
| Power Source | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | 100-127V/220-240V, 50/60Hz | Similar: Both use standard power supplies. Differences are in specific voltage/Hz and the predicate's optional battery. Concluded as similar. |
| Power Consumption | 14W | 65W | Similar: Different wattage, but implies it's not a safety/effectiveness concern. |
| Safety Feature | Button on display allows user to stop or pause therapy session at any time | Power button on main unit allows user to stop 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 |
| Dimensions | 4" x 5" x 9" | FO-3001: 220190113MM; FO-3008: 240200110MM | Similar: Different physical dimensions. |
| Number of Chambers | 5 or less | FO-3001: 4, 6, 8 Chambers for each unit; FO-3008: 4 Chambers for each unit | Similar: FO-3001 offers more chambers. This difference is not stated to adversely impact safety and effectiveness. |
| Housing Materials | Molded ABS enclosure | Molded ABS enclosure | Same |
2. Sample size used for the test set and the data provenance
The document states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable" (Page 4). This indicates that no clinical or animal studies were conducted for this 510(k) submission to demonstrate performance. The clearance is based on substantial equivalence to the predicate device through technological comparison and adherence to recognized consensus standards.
Therefore, there is no test set, sample size, or data provenance information provided in this document as it was not required for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical or animal performance testing was conducted, there was no test set, and therefore no experts were used to establish ground truth in the context of device performance. The evaluation was primarily engineering and regulatory.
4. Adjudication method for the test set
Not applicable, as no dedicated test set or clinical performance study was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an air compression therapy system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is hardware-based for physical therapy, not an algorithm or software. No standalone performance study was conducted.
7. The type of ground truth used
Not applicable, as no performance studies with a ground truth component were conducted. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the legally marketed predicate device (K160608), supported by the subject device's adherence to relevant technical standards.
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable, as this device does not involve machine learning or AI models with training sets.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 25, 2021
Foshan Hongfeng Co., Ltd % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room,No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China
Re: K201982
Trade/Device Name: Air compression therapy system FO-3001; Air compression therapy system FO-3008 Regulation Number: 21 CFR 890.5650
Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 17, 2020 Received: July 17, 2020
Dear Sam Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201982
Device Name
Air compression therapy system FO-3001; Air compression therapy system FO-3008
Indications for Use (Describe)
Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| Type of Submission | Traditional |
|---|---|
| Date Prepared | February 4, 2021 |
| Submission Sponsor | |
| Manufacturer Name | FOSHAN HONGFENG CO.,LTD. |
| Address | No.4-2 Leqiang Road, Leping Sanshui, Foshan,Guangdong, China |
| Tel | 86-0757-8392028 |
| 573619164@qq.com | |
| Contact Person | Dongfeng Cheng |
| Device Identification | |
| Trade Name | Air compression therapy system FO-3001;Air compression therapy system FO-3008 |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Power inflatable tube massager |
| Device Classification | Class II |
| Product Code | IRP |
| Panel | Physical Medicine |
| Previous Submissions | None |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co.,Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong NewDistrict, Shanghai, China |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.
Device Description
Indications for Use of the Device
Air compression therapy system Models FO-3001 and FO-3008: Air Pressure Therapy System is Section[006] Page 1 of 13
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consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
[Remainder of page left intentionally blank]
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Table 6A: Predicate Device Information
| No. | RegulationNumber | 510kNumber | Sponsor | Predicate DeviceName | Rx orOTC | TreatmentTime | PressureRange |
|---|---|---|---|---|---|---|---|
| 1 | 21 CFR890.5650 | K160608 | NormaTecIndustries, LP | NormaTec Pulseand NormaTecPulse Pro | OTC | Stays on until the user turns it off or can be set up toturn off in a range of 10 mins to continuous / Usercontrolled 10 minutes to 175 minutes or continuous –total time over 4 segments | 30-110mmHg |
Table 6B: Differences between Models
| Characteristic | Air Compression Therapy System: FO-3001 | Air Compression Therapy System: FO-3008 |
|---|---|---|
| Indications for use | × | × |
| OTC | × | × |
| Device Pressure Range | × | × |
| Treatment Time | × | × |
| Standard | × | × |
| Mode of Compression | × | × |
| Power Source | × | × |
| Power Consumption | × | × |
| Size and appearance of sleeves | × | × |
| Housing Materials | × | × |
Note: *"×" means same.
Section[006]
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| Safety Feature | ||
|---|---|---|
| Safety Feature | X | X |
| Technology | X | X |
| Dimensions | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Photo | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Number of Chambers | Different, see the Table 6C for details | Different, see the Table 6D for details |
| Work Mode | Different, see the Table 6C for details | Different, see the Table 6D for details |
Table 6C: Summary of Comparison of FO-3001
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device Name | Air compression therapy system: FO-3001 | NormaTec Pulse and NormaTec PulsePro | N/A |
| 510(k) number | K160608 | K160608 | N/A |
| Manufacturer | FOSHAN HONGFENG CO.,LTD. | NormaTec Industries, LP | N/A |
| Product Regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classification Name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| Regulation Class | 2 | 2 | Same |
| Product Code | IRP | IRP | Same |
| Indications foruse | Intended for home to temporarily relieveminor muscle aches and/or pains, promoteblood circulation in treated areas. | The NormaTec Pulse and Pulse Pro isan air pressure massager intended totemporarily relieve minor muscle achesand/or pains, and to temporarilyincrease circulation to the treated areas. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 30-110mmHg | 30-110mmHg | Same |
| TreatmentTime | 1-60mins | Stays on until the user turns it off orcan be set up to turn off in a range of10 mins to continuous / User controlled10 minutes to 175 minutes orcontinuous -total time over 4segments. | SimilarThe treatment time of subject device issmaller than predicate device (K160608)so the difference of treatment time wouldnot raise adversely impact on safety andeffectiveness. |
| Standard | IEC 60601-1-11:2015IEC 60601-1-2:2014IEC 60601-1:2005ISO 10993-10:2010ISO 10993-5:2009ISO 10993-12:2012 | ES 60601-1,IEC 60601-1-2,IEC 60601-1-11 | Similar |
| Mode ofCompression | Sequential | Sequential Gradient, Peristaltic andPulsing | Same |
| Power Source | 100-127V/220-240V, 50/60Hz | 12 VDC via an IEC 60601-1 compliantpower supply (100-240 VAC input) | Similar |
| Optional Integrated rechargeable battery | |||
| PowerConsumption | 65W | 14W | Similar |
| Dimensions(WHD) | 220190113MM | 4" x 5" x 9" | Similar |
| Photo | Image: Photo of a black device with buttons and a handle | Image: Photo of a black device with a screen | Similar |
| Size andappearance ofsleeves (legpart) | M:9165cm L:10074cmXL:110*70cm (Overlapping) | Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60" | Similar |
| HousingMaterials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number ofChambers | 4,6,8 Chambers for each unit | 5 or less | Similar |
| Work Mode | Image: Diagram of different work modes | Sequential mode:Starting with the distal chamber andprogressing up the proximal chamber, each section compresses and the pressure gradually rises to the | Although the subject device provides sixkinds of work mode, the Mode A is thesame with predicate device (K160608)while the other work modes of subject the device just have difference about the |
| 6 chambers: | pre-determined air pressure level, then | inflatable order of the different chambers | |
| A (Normal Mode): Chamber ① inflating tillsetup pressure or for 2 seconds, then hold airfor 2 seconds, start deflating; chamber ② startlike ①. Same way till chamber ⑥, pause for 3seconds, then restart chamber ①②③④⑤⑥again. | decompresses and the air pressuredrops.Once the top section decompresses, thecycle begins again. again. | The treatment pressure range are the sameunder different work modes, so thedifference of pressure range would not raiseadversely impact on safety andeffectiveness. | |
| B (Sequential Squeeze Mode): chamber ①inflating till set up pressure or for 28 seconds,then hold the pressure, chamber ② inflating,till setup pressure or for 28 seconds, thenchamber ①② hold pressure in same time,then chamber ③ start inflating, same way tillafter chamber ⑥. Chamber ①②③④⑤⑥deflating in same time for 3 seconds. Thenrepeat. | Normatec Pulse mode:Starting with the distal zone andprogressing up the proximal zone, onezone compresses and the pressuregradually rises to the pre-determinedair pressure level, holds the air ofprevious two zone, the other zones donot hold, until the last zone finished,deflate the all last three zone then enterinto next cycle. | ||
| C (Double Wave Mode: chamber ①②inflating till setup pressure or for 40 seconds,hold air for 2 seconds, then start deflating.Chamber ③④ start inflating till setup pressureor for 40 seconds, hold air for 2 seconds, thendeflating, same way for chamber ③④ tillchamber ⑤⑥, pause for 3 seconds. Thenrepeat. | |||
| D (Whole Squeeze Mode): chamber①②③④⑤⑥ inflating at the same time tillsetup pressure or for 90 seconds, thendeflating in the same time for 3 seconds. Then | |||
| Image: Diagram of air pressure | |||
| Image: Diagram of air pressure | |||
| repeat.E (Combined B + C): sequential squeeze +double waveF (Combined A + C + D): normal + doublewave + whole squeeze.4 and 8 chambers same as 6 chambers above. | |||
| Safety feature | Power button on main unit allows user to stoptherapy session at any time | Button on display allows user to stopor pause therapy session at any time | Same |
| Technology | Compressor and valve system whichsequentially inflates inflatable chambers | Compressor and valve system whichsequentially inflates inflatable chambers | Same |
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Table 6D: Summary of Comparison of FO-3008
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device Name | Air compression therapy system: FO-3008 | NormaTec Pulse and NormaTec Pulse Pro | N/A |
| 510(k) number | K160608 | N/A | |
| Manufacturer | FOSHAN HONGFENG CO.,LTD. | NormaTec Industries, LP | N/A |
| ProductRegulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| ClassificationName | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same |
| RegulationClass | 2 | 2 | Same |
| Product Code | IRP | IRP | Same |
| Indications foruse | Intended for home to temporarily relieveminor muscle aches and/or pains, promoteblood circulation in treated areas. | The NormaTec Pulse and Pulse Pro is an air pressuremassager intended to temporarily relieve minormuscle aches and/or pains, and to temporarily increasecirculation to the treated areas. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 30-110mmHg | 30-110mmHg | Same |
| TreatmentTime | 1-60mins | Stays on until the user turns it off or can be set up toturn off in a range of 10 mins to continuous / Usercontrolled 10 minutes to 175 minutes or continuous-total time over 4 segments. | SimilarThe treatment time ofsubject device is smallerthan predicate device(K160608), so the differenceof treatment time would notraise adversely impact onsafety and effectiveness. |
| Standard | IEC 60601-1-11:2015IEC 60601-1-2:2014IEC 60601-1:2005ISO 10993-10:2010ISO 10993-5:2009 | ES 60601-1,IEC 60601-1-2,IEC 60601-1-11 | Similar |
| ISO 10993-12:2012 | |||
| Mode ofCompression | Sequential | Sequential Gradient, Peristaltic and Pulsing | Same |
| Power Source | 100-127V/220-240V, 50/60Hz | 12 VDC via an IEC 60601-1 compliant power supply(100-240 VAC input) Optional Integrated rechargeablebattery | Similar |
| PowerConsumption | 65W | 14W | Similar |
| Dimensions(WHD) | 240200110MM | 4" x 5" x 9" | Similar |
| Photo | Image: White device with handle | Image: Black handheld device | Similar |
| Size andappearance ofsleeves (legpart) | Image: Leg sleeve | Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60" | Similar |
| HousingMaterials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number ofChambers | 4 Chambers for each unit | 5 or less | Similar |
| Work Mode | Image: [Diagram of chambers inflating]A (Normal Mode): Chamber ① inflating tillsetup pressure or for 2 seconds, then hold airfor 2 seconds, start deflating; chamber ② startlike ①. Same way till chamber ④, pause for 3seconds, then restart chamber ①②③④ again.B (Sequential Squeeze Mode): chamber ①inflating till set up pressure or for 28 seconds,then hold the pressure, chamber ② inflating,till setup pressure or for 28 seconds, thenchamber ①② hold pressure in same time,then chamber ③ start inflating, same way tillafter chamber ④. Chamber ①②③④deflating in same time for 3 seconds. Thenrepeat.C (Double Wave Mode: chamber ①②inflating till setup pressure or for 40 seconds,hold air for 2 seconds, then start deflating.Chamber ③④ start inflating till setup pressureor for 40 seconds, hold air for 2 seconds, thendeflating. | Sequential mode:Starting with the distal chamber and progressing upthe proximal chamber, each section compresses andthe pressure gradually rises to the pre-determined airpressure level, then decompresses and the air pressuredrops.Once the top section decompresses, the cycle beginsagain. again.Image: [Diagram of sequential mode]Normatec Pulse mode:Starting with the distal zone and progressing up theproximal zone, one zone compresses and the pressuregradually rises to the pre-determined air pressurelevel, holds the air of previous two zone , the otherzones do not hold, until the last zone finished, deflatethe all last three zone then enter into next cycle.Image: [Diagram of Normatec Pulse mode] | Although the subject deviceprovides four kinds of workmode, the Mode A is thesame with predicate device(K160608), while the otherwork modes of proposeddevice just have differenceabout the inflatable order ofthe different chambers. Thetreatment pressure range arethe same under differentwork modes, so thedifference of pressure rangewould not raise adverselyimpact on safety andeffectiveness. |
| Safety feature | Power button on main unit allows user to stop therapy session at any time | Button on display allows user to stop or pause therapy session at any time | Same |
| Technology | Compressor and valve system which sequentially inflates inflatable chambers | Compressor and valve system which sequentially inflates inflatable chambers | Same |
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Summary of the Technological Characteristics of the Device
The device meets all the applicable technical requirements of :
- IEC 60601-1-11: 2015 Medical electrical equipment Part 1-1: General requirements for ● basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance
- IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General Requirements for ● Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests for ● irritation and skin sensitization, an assessment is made of the potential of the material under test to produce dermal irritation in a relevant animal model
- ISO 10993-5:2009 Biological Evaluation of Medical Device Part 5: Tests for in vitro ● Cytotoxicity
- ISO 10993-12:2012 - Biological Evaluation of Medical Device - Part 12: Sample preparation and reference materials
Conclusion
Based on the indications for use, technological characteristics, and non-clinical performance data, Air compression therapy system Models FO-3001 and FO-3008 (510(K) number) is as safe and effective as the legally marketed predicate devices, NormaTec Pulse and NormaTec Pulse Pro(K160608).
§ 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).