(344 days)
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.
Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 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. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.
Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.
This document is a 510(k) premarket notification for a medical device called "Air Pressure Therapy System: VU-IPC04B". The FDA has determined the device is substantially equivalent to a legally marketed predicate device, "NormaTec Pulse and NormaTec Pulse Pro (K160608)".
Based on the provided text, the device in question is a Powered Inflatable Tube Massager (Product Code IRP), which falls under Class II medical devices.
Here's an analysis of the acceptance criteria and study proving the device meets them, according to the document:
1. A table of acceptance criteria and the reported device performance:
The document directly states: "Performance testing - clinical: Not Applicable." and "Performance testing - animal: Not Applicable." This indicates that for this specific type of device and its indications for use, no clinical or animal performance studies were required by the FDA or provided by the manufacturer to demonstrate meeting acceptance criteria for its therapeutic claims (temporary relief of muscle aches/pains, increased circulation).
Instead, the substantial equivalence hinges on:
- Indications for Use: The subject device's indications for use are identical to the predicate device.
- Technological Characteristics: The core technology (compressor and valve system for sequential inflation) is the same.
- Non-clinical Performance Data: This is where the "acceptance criteria" lie in this context, focusing on safety and technical specifications rather than direct clinical efficacy.
Here's a table summarizing the relevant "performance characteristics" and acceptance based on this document:
| Acceptance Criteria (Based on comparison to Predicate Device & Applicable Standards) | Reported Device Performance (VU-IPC04B) | Meets Criteria? |
|---|---|---|
| Indications for Use (Same as predicate) | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Yes (Identical) |
| Regulation Number (Same as predicate) | 21 CFR 890.5650 | Yes (Same) |
| Classification Name (Same as predicate) | Massager, Powered Inflatable Tube | Yes (Same) |
| Regulation Class (Same as predicate) | 2 | Yes (Same) |
| Product Code (Same as predicate) | IRP | Yes (Same) |
| Rx or OTC Use (Same as predicate) | OTC | Yes (Same) |
| Pressure Range (Same as predicate) | 30-110mmHg | Yes (Same) |
| Mode of Compression (Same as predicate) | Sequential | Yes (Same) |
| Safety Feature (Same as predicate) | Power button on main unit allows user to stop therapy session at any time. | Yes (Same) |
| Technology (Same as predicate) | Compressor and valve system which sequentially inflates inflatable chambers. | Yes (Same) |
| Standard Compliance (Non-clinical safety) | Meets IEC 60601-1-11: 2015, IEC 60601-1-2: 2014, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/R)2012, ISO 10993-5: 2009, ISO 10993-10: 2010, IEC 62133-2: 2017. | Yes |
| Treatment time (Similar to predicate without raising safety concerns) | 5-99 mins (Predicate: 10 mins to continuous / up to 175 mins) | Yes (Similar, with justification for no adverse impact) |
| Power source (Similar to predicate without raising safety concerns) | 110-240V; 50Hz/60Hz (Predicate: 100-240 VAC input) | Yes (Similar, implied no adverse impact) |
| Power consumption (Similar to predicate without raising safety concerns) | 35W (Predicate: 14W) | Yes (Similar, implied no adverse impact) |
| Dimensions/Weight (Similar to predicate without raising safety concerns) | Various (Predicate: 4"x5"x9" / 3.6 lbs) | Yes (Similar, implied no adverse impact) |
| Number of chambers (Similar to predicate without raising safety concerns) | 6 chambers (Predicate: 5 chambers) | Yes (Similar, implied no adverse impact) |
| Work modes (Similar to predicate without raising safety concerns) | Mode A (sequential), Mode B (gradual fill), Mode C (pulse), Mode D (all chambers inflate together) (Predicate: Sequential, Pulse) | Yes (Similar, with justification for no adverse impact) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical or animal test set data was used for performance validation as per the document. The substantial equivalence is based on comparison to a predicate device and engineering/bench testing against recognized standards.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert-adjudicated test set was used for performance assessment in this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- Not applicable. This device is an Air Pressure Therapy System, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is not an algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) relies on the established safety and effectiveness of the legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro), combined with compliance to recognized international and national electrical, safety, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series) through non-clinical (bench) testing. There is no "ground truth" derived from patient outcomes or expert consensus for this specific device's clinical performance, as clinical studies were deemed unnecessary for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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June 22, 2021
Xiamen Weiyou Intelligent Technology 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: K201935
Trade/Device Name: Air Pressure Therapy System: VU-IPC04B Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: February 3, 2021 Received: June 2, 2021
Dear Sam Lin:
We have reviewed vour 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 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,
Heather Dean, PhD Assistant Director. Acute Injurv 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) K201935
Device Name
Air Pressure Therapy System: VU-IPC04B
Indications for Use (Describe)
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.
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 3, 2021 |
| Submission sponsor | |
| Manufacturer name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 101-401, No.6 Xianghong Road, Xiang'an District, Xiamen,Fujian, China |
| Tel | 86-0592-6251545 |
| 17916220@qq.com | |
| Contact person | Yong Sun |
| Device identification | |
| Classification name | Massager, Powered Inflatable Tube |
| Trade name | Air Pressure Therapy System: VU-IPC04B |
| Device classification | Class II |
| Regulation number | 21 CFR 890.5650 |
| Panel | Physical Medicine |
| Product code | IRP |
| Previous submissions | None |
| Application correspondent | |
| Company name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District,Shanghai, China |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact person | Sam Lin |
| Predicate and reference device information | |
| Sponsor | NORMATEC INDUSTRIES, LP X |
|---|---|
| Trade/Device name | NormaTec Pulse and NormaTec Pulse Pro |
| 510K number | K160608 |
| Regulation number | 21 CFR 890.5650 |
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Indications for use of the device
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.
Device description
Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 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. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.
Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.
Performance testing - clinical
Not Applicable.
Performance testing - animal
Not Applicable.
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| Subject device | Predicate device | Differences discussion | ||
|---|---|---|---|---|
| Device name | Air Pressure Therapy System: VU-IPC04B | NormaTec Pulse and NormaTec PulsePro | ||
| 510(k) number | K201935 | K160608 | N/A | |
| Manufacturer | Xiamen Weiyou Intelligent Technology Co., Ltd. | NORMATEC INDUSTRIES, LP X | 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 Pressure Therapy System VU-IPC04B isintended to temporarily relieve minor muscle achesand/or pains, and to temporarily increase circulationto the treated areas. | The NormaTec Pulse and Pulse Pro isan air pressure massager intended totemporarily relieve minor muscleaches and/or pains, and to temporarilyincrease circulation to the treatedareas. | Same | |
| Rx or OTC | OTC | OTC | Same | |
| Pressure range | 30-110mmHg | 30-110mmHg | Same | |
| Treatment time | 5-99mins | Stays on until the user turns it off orcan be set up to turn off in a range of10 mins to continuous / Usercontrolled 10 minutes to 175 minutesor continuous -total time over 4 | SimilarThe treatment time of subjectdevice is smaller thanpredicate device (K160608)so the difference of treatment | |
| segments. | time would not raise adverselyimpact on safety andeffectiveness. | |||
| Standard | IEC 60601-1-11,ES60601-1:2005/(R)2012C1:2009/(R)2012 and60601-1-2, ISO 10993-10,62133-2 | ANSI AAMI A1:2012,and A2:2010/(R)2012, IECISO 10993-5, IEC | ES 60601-1, IEC 60601-1-2, IEC60601-1-11 | Similar |
| Mode of compression | Sequential | Sequential | Same | |
| Power source | 110-240V; 50Hz/60Hz | 100- 240 VAC input | Similar | |
| Power consumption | 35W | 14W | Similar | |
| Dimensions(WHD) | 22149CM | 4" x 5" x 9" | Similar | |
| Weight | 1.6KG | 3.6 pounds | Similar | |
| Photo | Image: a black device with buttons | N/A | Similar | |
| Size and appearance ofsleeves (leg part) | Image: two black sleeves and a black round objectM: 91x65cmXL: 110x70cm(overlapping)XXL: 125x76cm(overlapping) | Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60" | Similar | |
| Housing materials | Molded ABS enclosure | Molded ABS enclosure | Same | |
| Number of chambers | 6 chambers | 5 chambers | Similar | |
| Mode A: | Sequential mode: | Although the subject device | ||
| In this mode, only a single chamber is inflated at atime. Starting from the chamber ① and working up | Starting with the distal chamber and | provides 4 kinds of work | ||
| to the chamber ⑥. Then the cycle repeats. | progressing up the proximal chamber, | mode, the Mode A and Mode | ||
| Mode B: | each section compresses and the | C are the same with predicate | ||
| In this mode, the chamber ① stays inflated. It | pressure gradually rises to the | device (K160608), while the | ||
| gradually adds a chamber until all six chambers are | pre-determined air pressure level, | other work modes of subject | ||
| filled with air. Then the cycle repeats. | then decompresses and the airpressure drops. | device just have difference | ||
| Mode C: | Once the top section decompresses,the cycle begins again. again. | about inflatable order of the | ||
| In this mode, chamber ① inflates & deflates 4 times,then holds pressure; next chamber ② inflates & | Image: Diagram of sequential mode | different chambers. The | ||
| deflates 4 times, chamber ①② hold pressure; | treatment pressure range are | |||
| chamber ③ inflates & deflates 4 times, chamber | the same under different work | |||
| Work mode | ②③ hold pressure, chamber ① deflates; chamber ④ | modes, so the difference of | ||
| inflates & deflates 4 times, chamber ③④ hold | pressure range would not raise | |||
| pressure, chamber ② deflates; working as this way | adversely impact on safety | |||
| up to chamber ⑥. Then the cycle repeats. | and effectiveness. | |||
| Note: Under this mode, for the FIRST CYCLE, itworks as mode B to warm up; from the 2nd cycle on,it works as PULSE Mode C. | ||||
| Mode D: | 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 thenenter into next cycle. | |||
| In this mode, all chambers inflates together, anddeflates together. Then the cycle repeats. | ||||
| A:In this mode, only a single chamber is inflated at a time. Starting from the chamber 1and working up to the chamber 6 Then the cycle repeats.Image: Diagram of chambers inflating one at a time, numbered 1 through 6B:In this mode, the chamber 1 stays inflated. It gradually adds a chamber until allsix chambers are filled with air. Then the cycle repeats.Image: Diagram of chambers inflating sequentially, numbered 1 through 6C:In this mode, chamber 1 inflates & deflates 4 times, then holds pressure;next chamber 2 inflates & deflates 4 times, chamber 12 hold pressure;chamber 3 inflates & deflates 4 times, chamber 23 hold pressure, chamber 1 deflates;chamber 4 inflates & deflates 4 times, chamber 34 hold pressure, chamber 2 deflates;working as this way up to chamber 6 Then the cycle repeats.Image: Diagram of chambers inflating and deflating, numbered 1 through 6, with a pulse iconNote: 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.D:In this mode, all chambers inflates together, and deflates together.Then the cycle repeats.Image: Diagram of chambers inflating and deflating together, numbered 1 through 6 | Image: Diagram of zones pulsing and holding | |||
| Safety feature | Power button on main unit allows user to stoptherapy session at any time | Power button on main unit allowsuser to stop therapy session at anytime | Same | |
| Technology | Compressor and valve system which sequentiallyinflates inflatable chambers | Compressor and valve system whichsequentially inflates inflatablechambers | Same |
Table 6A: Summary of Comparison
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Performance Characteristic
The device meets all the applicable technical requirements of :
IEC 60601-1-11: 2015 - Medical electrical equirements 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 AAMI 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 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
Conclusion
Based on the indications for use, technological characteristics, and non-clinical performance data, "Air Pressure Therapy System: VU-PC04B (K20193)' is as safe, as effective, and performs as well as the legally marketed 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).