(90 days)
No
The device description details a manual/analog pump and fixed, pre-programmed pressure gradients and cycle times. There is no mention of adaptive learning, data processing for decision making, or any components typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas," classifying it as a device providing therapeutic benefits.
No
The device description and intended use indicate that it is a sequential pneumatic compression device used for temporary relief of muscle aches and pains and increased circulation, not for diagnosing conditions.
No
The device description explicitly details hardware components: a pneumatic manual/analog pump and a limb sleeve/garment with chambers. It describes the physical mechanism of operation (air flow, inflation, deflation) and mentions a calibrated dial gauge. This is not a software-only device.
Based on the provided information, the Powerpress Recovery Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of minor muscle aches and pains and temporary increase in circulation. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a pneumatic compression device that applies external pressure to a limb. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting markers, or providing information about a patient's health status based on in vitro testing.
In summary, the Powerpress Recovery Unit is a physical therapy or recovery device, not an IVD.
N/A
Intended Use / Indications for Use
The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
Powerpress Recovery Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components.
- Pneumatic Manual / Analog Pump .
- . Limb Sleeve or garment composes of 4 chambers
Powerpress Recovery Unit enables different treatment pressure (30 ~ 100mmHg). When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting.
Gradient: appx 7%, example: Foot 60mmHg – Ankle 56mmHg – Calf 52mmHg - Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) – 36 sec, 2nd chamber(ankle) – 27 sec, 3rd chamber(calf) - 18 sec, 4th chamber(thigh) - 9 sec
A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, Athlete Training and Clinics environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been tested to the requirements of the following standards:
IEC 60601-1:2005+AMD1:2012 .
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
. IEC 60601-1-2: 2014
Collateral standard: Electromagnetic Compatibility - Requirements and Tests -
IEC 60601-1-6:2010+AMD1:2013 ●
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability -
IEC 60601-1-11: 2015
Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment -
ISO 10993 Compression Garment Skin Sensitization Test Report
Animal: No animal testing was performed
Clinical: No clinical testing was performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
October 21, 2020
Hanuri Distribution, Inc Jung Moon President 9601 Owensmouth Ave. # 8 Chatsworth, California 91311
Re: K202044
Trade/Device Name: Powerpress Recovery Unit Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 13, 2020 Received: July 23, 2020
Dear Jung Moon:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Amber Ballard, PhD Assistant Director 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)
Device Name POWERPRESS RECOVERY UNIT
Indications for Use (Describe)
The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
(as required by 21 CFR 807.92)
A. 510K Number : K202044
- B. Date: October 20, 2020
C. Applicant
Company & Manufacturer Name: Hanuri Distribution, Inc Address: 9601 Owensmouth Ave. # 8 Chatsworth, CA 91311 USA Owner & Contact Person: Jung H Moon Phone: 818-998-1023, Fax: 818-998-0277 Email: info@air1000.com
D. Regulatory Information
-
- Proprietary/Trade Name: Powerpress Recovery Unit
-
- Regulation Name (Common/Usual Name): Powered inflatable tube massager
-
- Regulation Number: 21 CFR 890.5650
-
- Product Code: IRP
-
- Regulatory Class: Class II
- E. Indications for Use
The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.
- F. Environment of Use: Home, Athlete Training and Clinics environments
- G. Warning:
Do not use the compressor to direct pressurized air towards your eyes, nose, mouth, or ears. Doing so may lead to a serious injury
- H. Predicate Device
Powerpress Recovery Unit is substantially equivalent to the following
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| DJS Massager; Recovery | ||
| Pump 701-E; Recovery Pump | ||
| 701RA | MEGO AFEK AC LTD | K112479 |
I. Device Description
Powerpress Recovery Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components.
4
- Pneumatic Manual / Analog Pump .
- . Limb Sleeve or garment composes of 4 chambers
Powerpress Recovery Unit enables different treatment pressure (30 ~ 100mmHg). When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting.
Gradient: appx 7%, example: Foot 60mmHg – Ankle 56mmHg – Calf 52mmHg - Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1* chamber(foot) – 36 sec, 2nd chamber(ankle) – 27 sec, 3rd chamber(calf) - 18 sec, 4th chamber(thigh) - 9 sec
A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg
- J. Substantial Equivalence of Technological Characteristics
Powerpress Recovery Unit Model PR1000 Massage Systems and the predicate device all provide sequential inflation pressure from distal to proximal segments. Both the Powerpress Recovery Unit and predicate devices offer adjustable pressure ranges.
The Powerpress Recovery Unit have decreasing gradient pressures from distal to proximal segments.while predicate device does not have decreasing gradient pressures. The Powerpress Recovery Unit provide continuously adjustable pressure in the range between 30 to 100 mmHg. while the predicate device provides three pressure adjustments options in increments of low, medium and high pressure ranges within the 20 to 80 mmHg range. The Powerpress Recovery Unit have fixed cycle times that are fixed by a motorized valve, and are independent of garment size and number (one or two garments). The predicate device does not have a motorized valve and uses back pressure to trigger the cycle to the next chamber of the garment.
A difference in the subject device from the predicate is that the Powerpress recovery unit has a pressure range from 30 mmHg to 100 mmHg while predicate device has from 20 mmHg to 80 mmHg. But there are FDA cleared devices for same intended use, which are shown in the table below, prove that our pressure range raises no new questions of safety and effectiveness. Also Electrical Safety Test (IEC 60601-1:2005+AMD1:2012) verifies that the technological differences in the fuse rating, power consumption, electric power plug, size and net weight of device do not raise different questions of safety and effectiveness.
5
| MANUFACTURER | 510(k)
Number | TRADE NAME | PRESSURE RANGE | PRESCRIPTION OR
OTC |
|-------------------------|------------------|------------------------------------------|---------------------|------------------------|
| MEGO AFEK AC LTD | K140519 | Recovery Pump 737R | 20 mmHg to 100 mmHg | OTC |
| NormaTec Industries, LP | K160608 | NormaTec Pulse and
NormaTec Pulse Pro | 30 mmHg to 110 mmHg | OTC |
The Powerpress Recovery Unit operate within clinically-established parameters. The differences between the predicate and the applicant devices do not impact safety or effectiveness. A table illustrating the substantial equivalence comparison table is provided below.
K. Substantial Equivalence Comparison Table
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Manufacturer | Hanuri Distribution, Inc | MEGO AFEK AC LTD | Different |
| 510(k) Number | K202044 | K112479 | N/A |
| Proprietary / | |||
| Trade Name | Powerpress Recovery Unit | DJS Recovery Pump 701RA | Different |
| Regulation Name | Powered Inflatable Tube Massager | Powered Inflatable Tube Massager | Identical |
| Regulation | |||
| Number | 21 CFR 890.5650 | 21 CFR 890.5650 | Identical |
| Product Code | IRP | IRP | Identical |
| Regulatory Class | II | II | Identical |
| Indications for | |||
| Use | The Powerpress Recovery Unit is indicated for | ||
| the temporary relief of minor muscle aches and | |||
| pains, and for temporary increase in circulation | |||
| to the treated areas in people who are in good | |||
| health. The Powerpress Recovery Unit | |||
| simulates kneading and stroking of tissues by | |||
| using inflatable garment. | The DJS Massager is indicated for the | ||
| temporary relief of minor muscle aches and | |||
| pains, and for temporary increase in | |||
| circulation to the treated areas in people who | |||
| are in good health. The DJS Massager | |||
| simulates kneading and stroking of tissues by | |||
| using inflatable garment. | Identical | ||
| Contraindications | * Do not use this product if you are | ||
| experiencing inflammation, an infection, pain | |||
| of unknown origin, or bleeding (internal or | |||
| external) at or near the site of application or if | |||
| you have a wound at or near the site of | |||
| application. |
- Do not use this product if you are under the
care of a physician or have a condition
requiring the use of any medical device. - Do not use this product on sensitive skin or
on in the presence of poor circulation. - Do not use this product if you have any of the
following conditions:
o Acute pulmonary edema
o Acute thrombophlebitis
o Acute congestive cardiac failure
o Acute infections | *This device is intended for use by people in
good health. This device is not recommended
for people who have heart problems, or
vascular problems, have a condition
requiring the use of any medical device, or
have any condition that might affect their
normal well being.
*If you are, or may be, pregnant, consult
with your physician before use.
*Do not use this device over insensitive or
numb areas, or phlebitis. This device should
not be used over swollen or inflamed areas or
skin eruptions. Do not use in the presence of
unexplained calf pain.
*Consult your physician prior to use | Similar |
| | o Deep Vein Thrombosis (DVT)
o Episodes of Pulmonary embolism
o Wounds lesions or tumors at or in the
vicinity of application
o Where increased venous and lymphatic
return is undesirable
o Bone fractures or dislocations at or in the
vicinity of application
o Please consult a physician before using this
device if:
a) If you are pregnant for feel weak
b) If you have an implant at the site of
application
c) If you have a cardiac pacemaker | | |
| Prescriptive or
OTC | OTC | OTC | Identical |
| Pressure Range | 30 - 100 mmHg | 20 – 80 mmHg | Similar |
| Time Setting | No Timer, Continuous Mode | No Timer, Continuous Mode | Identical |
| Compression
Mode | Gradient Sequential | Gradient Sequential | Identical |
| Number of Mode | 1 Mode | 1 Mode | Identical |
| Chamber of
Garment | 4 Chamber (Air Compartments Garment)
Overlap Each Chamber | 4 Chamber (Air Compartments Garment)
Overlap Each Chamber | Identical |
| Treatment Time | 15 min to 45 min | 15 min to 45 min | Identical |
| Pressure Lock
Button | YES | YES | Identical |
| Single or Double
Garment
Available | YES | YES | Identical |
| Overload
Protection Fuses | This device is equipped with two overload
fuses, on each of the power lines | This device is equipped with two overload
fuses, on each of the power lines | Identical |
| Size of Device | H 5.12" x L 11.81" x W 8.27" | H 3.9" x L 10.2" x W 5.1" | Similar |
| Net Weight | 4.5 LBS | 5.1 LBS | Similar |
| Power
Consumption | 20 watts | 11 watts | Similar |
| Power Source(s) | 115V / 50 or 60 Hz | 115V / 50 or 60 Hz | Identical |
| Fuse Rating | 0.5 A | 2 A | Similar |
| Electric Plug | 2 Prong Plug | Three-pin Plug | Similar |
| Software | Manual / Analog (not software driven) | Manual / Analog (not software driven) | Identical |
| Material of
Garments | 200 denier nylon with a Polyurethane | 200 denier nylon with a Polyurethane | Identical |
6
L. Compression Garment Description
- a) List all types of compression garments
Half Leg Garment Large Item No. 1016 Half Leg Garment X Large Item No. 1016-A Full Leg Garment Large Item No. 1014 Full Leg Garment X Large Item No. 1014-A
7
- b) Description of every type of compression garment
-
- Half Leg Garment Large Item No. 1016 4 Chamber Overlapping Sequential Compression Garment Length from Floor to Top 19.5" / Length from Ankle to Top 18" Top (Knee) Circumference Measurement: 20" Mid Calf Circumference Measurement: 18" Ankle Circumference Measurement: 15"
-
- Half Leg Garment X Large Item No. 1016-A 4 Chamber Overlapping Sequential Compression Garment Length from Floor to Top 19.5" / Length from Ankle to Top 18" Top (Knee) Circumference Measurement: 25" Mid Calf Circumference Measurement: 23" Ankle Circumference Measurement: 19"
-
- Full Leg Garment Large Item No. 1014 4 Chamber Overlapping Sequential Compression Garment Length from Floor to Top 30" / Length from Ankle to Top 28" Top (Mid Thigh) Circumference Measurement: 24" Knee Circumference Measurement: 20" Mid Calf Circumference Measurement: 18" Ankle Circumference Measurement: 15"
-
- Full Leg Garment Large Item No. 1014-A 4 Chamber Overlapping Sequential Compression Garment Length from Floor to Top 30" / Length from Ankle to Top 28" Top (Mid Thigh) Circumference Measurement: 30" Knee Circumference Measurement: 25" Mid Calf Circumference Measurement: 23" Ankle Circumference Measurement: 19"
-
- c) Identify whether each type of compression garment you intend to market with your device has received prior 510(k) clearance or has not received prior 510(k) clearance
All of above compression garment has received prior 510(k) clearance. 510(k) number K110276
M. Technological Characteristics
The manufacturer believes that the technological characteristic of the Powerpress Recovery Unit is substantially similar to those of the predicate devices.
Powerpress Recovery Unit has very similar components to its predicate devices and very similar principles of operation.
- N. Performance Testing Bench:
8
The device has been tested to the requirements of the following standards:
IEC 60601-1:2005+AMD1:2012 .
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
. IEC 60601-1-2: 2014
Collateral standard: Electromagnetic Compatibility - Requirements and Tests -
IEC 60601-1-6:2010+AMD1:2013 ●
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability -
IEC 60601-1-11: 2015
Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment -
ISO 10993 Compression Garment Skin Sensitization Test Report
Animal: No animal testing was performed
Clinical: No clinical testing was performed
O. Conclusion
Powerpress recovery unit is substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the Substantial Equivalence of Technological Characteristics above do not raise questions of safety and effectiveness.