(47 days)
Not Found
No
The description details a standard electromechanical device with user-controlled settings and a microprocessor for basic control, with no mention of AI or ML capabilities.
Yes
The device is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated, which are therapeutic effects.
No
Explanation: The device is intended to treat post-surgical and acute injuries by reducing edema, swelling, and pain through cold and compression therapies. It does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including a control unit, hose assembly, and therapy wrap, which are essential for delivering the intended cold and compression therapies. While the control unit is software-controlled, the device as a whole is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to treat post-surgical and acute injuries by applying cold and compression to reduce edema, swelling, and pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device works by circulating cooled water and air through a therapy wrap applied to the body. It measures and controls temperature and compression levels. These are physical parameters applied externally to the body for treatment.
- No mention of analyzing biological samples: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
The device is a therapeutic device used for physical therapy and pain management.
N/A
Device Name: Nice1
Intended Use / Indications for Use
The Nicel combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.
Product codes
IRP, ILO
Device Description
Nice1 is a cold and compression therapy device used to aid recovery and reduce pain associated with soft tissue injuries. The device works by circulating cooled water and air through a therapy wrap that is placed on the injured body part. The cooled water circulates through the therapy wrap and provides cold therapy; the air inflates the therapy wrap causing it to compress around the injured body part.
The Nice1 uses thermoelectric technology to chill the water. The Nice1 consists of 3 key components:
- The control unit which chills the water and contains the pneumatic system for inflating and deflating the therapy wraps.
- The hose assembly which connects to the control unit to the therapy wrap and provides conduits for the flow of water and air to and from the therapy wrap.
- The therapy wrap which is placed on the patient and wraps around the injured body part to deliver cold and compression therapy.
The control unit is an electromechanical, software-controlled device housed in a plastic enclosure. The device is approximately 8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are a thermoelectric heat exchange for cooling the water, a pneumatic system to control the flow of air to/from the therapy wrap to regulate compression, and electronics to control the therapy. Integrated into the plastic enclosure is graphical touch screen that displays outputs and receives inputs from the user. Temperature, compression levels and therapy duration are selected by the user via the graphical touch screen interface and controlled by a microprocessor.
The control unit contains a 300ml reservoir that is filled with water by the user. Water from the reservoir is cooled by passing through the thermoelectric heat exchange; it is then pumped from the control unit through the hose assembly, through the therapy wrap and then returns to the control unit to be re-chilled. Temperature is controlled in five (5) levels ranging in temperature from 59°F to 43°F.
Compression can be set at low, medium and high settings ranging from 0 mmHg to 75 mmHg. The compression cycles from high to low on 2 – 5 minute intervals to achieve Intermittent Pneumatic Compression.
The hose assembly is 6 feet long and consists of a foam rubber outer sheath to provide insulation and 3 urethane tubes that carry water and air to/from the control unit and therapy wrap.
The therapy wraps are comprised of 3 layers of urethane coated nylon that are welded together to make 2 separate air and liquid tight layers for the air and water. The therapy wraps are tailored to fit specific body parts. At the current time the company is only marketing a knee wrap. Therapy wraps use a Velcro closure to allow for customized fitting for different patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts where therapy wraps are placed, specifically a knee wrap is currently marketed.
Indicated Patient Age Range
Adults. Children under 18 can use the device only under the supervision of a licensed healthcare practitioner.
Intended User / Care Setting
Healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to demonstrate substantial equivalence.
- Cold Therapy: The Nice1 and Game Ready operate at similar therapeutic temperatures. The coldest temperature for the Nice1 is 43 degrees F while the coldest temperature for Game Ready is 37 degrees F. The Game Ready reaches cold temperatures quicker than Nice1 because Game Ready uses ice to cool water, while Nice1 uses thermoelectric technology which requires 5-10 minutes to reach target low temperature.
- Compression Therapy: The Nice1 and Game Ready devices both operate at the same compression levels and cycle times.
High setting: both inflate to 75 mmHg for 2.5 minutes and deflate to 5 mmHg for 1 minute.
Medium setting: both inflate to 50 mmHg for 2.5 minutes and deflate to 5 mmHg for 1 minute.
Low setting: both inflate to 15 mmHg for 4.5 minutes and deflate to 5 mmHg for 1 minute.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Game Ready System, CoolSystems Inc., K071050
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Nice Recovery Systems, LLC c/o Dave Yungvirt, CEO Third Party Review Group 45 Rockefeller Plaza Suite 2000 New York, New York 10111
Re: K143197
Trade/Device Name: Nice1 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, ILO Dated: December 8, 2014 Received: December 9, 2014
Dear Dave Yungvirt,
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. 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143197
Device Name Nice1
Indications for Use (Describe)
The Nicel combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image contains the logo for NICE Recovery Systems. The word "nice" is written in large, orange, sans-serif font. Below "nice" is the phrase "Recovery Systems" in a smaller, gray, sans-serif font.
Traditional 510(k) Summary as required by Section 21CFR 807.92(c)
| Submitter/Owner | Nice Recovery Systems LLC |
|---|---|
| CEO: Michael Ross | |
| 1382 Kalmia Avenue | |
| Boulder, CO 80304 | |
| phone: 1-646-675-7700 | |
| fax: 1-720-302-1262 |
| Contact Person | Michael Ross
Nice Recovery Systems LLC
1382 Kalmia Avenue
Boulder, CO 80304
phone: 646-675-7700
fax: 1-720-302-1262
mr@nicerecovery.com |
| ---------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Date the summary was
| prepared | December 5, 2014 |
|---|---|
| ---------------------------------- | ------------------ |
| Name of the Device | Trade Name: Nice1
Common Name: Cold/Compression Therapy System |
| -------------------- | ------------------------------------------------------------------- |
|---|
| Classification | Classification Name: Cold water circulating pack/Powered |
|---|---|
| inflatable tube massager | |
| Primary Product Code: IRP | |
| Secondary Product Code: ILO | |
| Class II | |
| 890.5650 | |
| Physical Medicine |
| Manufacturing Facility | Sparton Medical Systems Colorado
4300 Godding Hollow Parkway
Frederick, CO 80504
Establishment Registration Number: 1724385 |
| ------------------------ | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Predicate Device | Game Ready System |
|---|---|
| Manufactured by CoolSystems Inc. | |
| K071050 | |
| Product Code: ILO/IRP | |
| Class II | |
| Cold water circulating pack/Powered inflatable tube massager |
Page 1 of 6
Nice Recovery Systems LLC, 1382 Kalmia Ave., Boulder, CO 80304
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Image /page/5/Picture/0 description: The image shows the logo for Nice Recovery Systems. The word "nice" is written in large, orange, sans-serif font. Below the word "nice" is the phrase "Recovery Systems" written in a smaller, gray, sans-serif font. The logo is simple and modern.
| Device Description | Nice1 is a cold and compression therapy device used to aid
recovery and reduce pain associated with soft tissue injuries. The
device works by circulating cooled water and air through a
therapy wrap that is placed on the injured body part. The cooled
water circulates through the therapy wrap and provides cold
therapy; the air inflates the therapy wrap causing it to compress
around the injured body part. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Nice1 uses thermoelectric technology to chill the water.
The Nice1 consists of 3 key components:
- The control unit which chills the water and contains the
pneumatic system for inflating and deflating the therapy
wraps. - The hose assembly which connects to the control unit to
the therapy wrap and provides conduits for the flow of
water and air to and from the therapy wrap. - The therapy wrap which is placed on the patient and
wraps around the injured body part to deliver cold and
compression therapy. |
| | The control unit is an electromechanical, software-controlled
device housed in a plastic enclosure. The device is approximately
8 x 7.64 x 8" and weighs 10 lbs. Inside the control unit are a
thermoelectric heat exchange for cooling the water, a pneumatic
system to control the flow of air to/from the therapy wrap to
regulate compression, and electronics to control the therapy.
Integrated into the plastic enclosure is graphical touch screen that
displays outputs and receives inputs from the user. Temperature,
compression levels and therapy duration are selected by the user
via the graphical touch screen interface and controlled by a
microprocessor. |
| | The control unit contains a 300ml reservoir that is filled with
water by the user. Water from the reservoir is cooled by passing
through the thermoelectric heat exchange; it is then pumped from
the control unit through the hose assembly, through the therapy
wrap and then returns to the control unit to be re-chilled.
Temperature is controlled in five (5) levels ranging in
temperature from 59°F to 43°F. |
| | Compression can be set at low, medium and high settings ranging
from 0 mmHg to 75 mmHg. The compression cycles from high
to low on 2 – 5 minute intervals to achieve Intermittent |
| | Pneumatic Compression. |
| | The hose assembly is 6 feet long and consists of a foam rubber
outer sheath to provide insulation and 3 urethane tubes that carry
water and air to/from the control unit and therapy wrap. |
| | The therapy wraps are comprised of 3 layers of urethane coated
nylon that are welded together to make 2 separate air and liquid
tight layers for the air and water. The therapy wraps are tailored
to fit specific body parts. At the current time the company is only
marketing a knee wrap. Therapy wraps use a Velcro closure to
allow for customized fitting for different patients. |
| | |
| Intended Use | The Nice1 combines cold and compression therapies. It is
intended to treat post-surgical and acute injuries to reduce edema, |
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Image /page/6/Picture/0 description: The image contains the logo for NICE Recovery Systems. The word "nice" is written in large, orange, sans-serif font. Below it, the words "Recovery Systems" are written in a smaller, gray, sans-serif font. The logo is simple and modern.
| swelling, and pain where cold and compression are indicated. It |
|---|
| Summary of Technological | Nice1 and Game Ready have substantially equivalent functions: |
|---|---|
| Characteristics in | -Both devices pump cooled water through a hose and therapy |
| Comparison to Predicate | wrap that is placed on the injured body part of the patient. |
| -Both devices inflate and deflate the therapy wrap and regulate air | |
| pressure to achieve Intermittent Pneumatic Compression. | |
| -Both devices use a microprocessor to control water temperature, | |
| compression levels and therapy duration. | |
| -Both devices have therapy wraps that correspond to specific | |
| body parts. | |
| -Both devices use therapy wraps that are comprised of 3 layers of | |
| urethane coated nylon that are welded together to make 2 separate | |
| air and liquid tight layers for the air and water. | |
| Nice1 differs from Game Ready in only 3 significant aspects: | |
| Nice1 uses thermoelectric technology to cool the water, so |
-
|
| | the patient only needs to add water to the reservoir. Game |
| | Ready uses ice to cool the water, so the patient must fill |
| | the reservoir with both ice and water. |
| | 2.
Because Nice1 and Game Ready use different methods to |
| | cool the water (thermoelectric vs. ice) the devices use |
| | different water flow rates to maintain the same levels of |
| | cold therapy. The differing flow rates are completely |
| | transparent to the user as the user is only aware of the cold |
| | therapy which is identical regardless of the fact that the |
| | water is flowing at different rates inside of the system. |
| | 3.
Nice1 uses a graphical touch screen to display options and |
| | |
| | messages as well as receive inputs from the user. Game Ready uses physical dials, buttons and a liquid crystal display to display options and messages as well as receive inputs from the user. Both products have substantially equivalent functions and provide equivalent therapies. |
| Non-clinical Testing | Nice1 complies with AAMI ANSI ES60601-1:2005/(R)2012, AI:2012 general requirements for electrical safety and IEC 60601-1-2:2007 electromagnetic compatibility.
Substantial equivalence with the predicate device is supported by Performance testing. Performance data demonstrates comparable results for cold therapy and compression therapy. A summary of the testing results follows: |
| | 1. Cold Therapy: The Nicel and Game Ready operate at similar therapeutic temperatures. The coldest temperature for the Nice1 is 43 degrees F while the coldest temperature for Game Ready is 37 degrees F. |
| | The main difference demonstrated in non-clinical testing was that the Game Ready reaches cold temperatures quicker than Nicel because it uses ice to cool water. Ice has an almost instantaneous effect while the thermoelectric technology used by Nicel requires a cool-down time of approximately 5 – 10 minutes to reach the target low temperature. |
| | 2. Compression Therapy: Compression Therapy: The Nicel and Game Ready devices both operate at the same compression levels and cycle times. |
| | At the High setting: the Nicel inflated to 75 mmHg for 2.5 minutes and then deflated to 5 mmHg for 1 minute. The Game Ready inflated to 75 mmHg for 2.5 minutes and deflated to 5 mmHg for 1 minute. |
| | At the Medium setting: the Nicel inflated to 50 mmHg for 2.5 minutes and then deflated to 5 mmHg for 1 minute. The Game Ready inflated to 50 mmHg for 2.5 minutes and deflated to 5 mmHg for 1 minute. |
| | At the Low setting: the Nicel inflated to 15 mmHg for 4.5 minutes and then deflated to 5 mmHg for 1 minute. The |
| | Game Ready inflated to 15 mmHg for 4.5 minutes and
deflated to 5 mmHg for 1 minute. |
| Conclusions from Non-Clinical Testing | Testing demonstrates that the Nice1 is as safe, as effective, and performs as well as the Game Ready device. |
| Clinical Testing | No clinical testing data are submitted, referenced or relied on to determine substantial equivalence. |
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Image /page/7/Picture/0 description: The image shows the logo for Nice Recovery Systems. The word "nice" is written in large, orange, sans-serif letters. Below the word "nice" is the phrase "Recovery Systems" in a smaller, gray, sans-serif font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image contains the logo for "nice Recovery Systems". The word "nice" is in orange, and the words "Recovery Systems" are in gray. The word "nice" is in a larger font than the words "Recovery Systems". The logo is simple and modern.
| Substantial Equivalence | The Nice1 is substantially equivalent to the Game Ready System,
CoolSystems Inc., K071050, Product Code ILO/IRP for cooling
and compression based on intended use, design, energy delivered,
performance, safety and bench testing. |
| ------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Feature | Nice1 | Game Ready, K071050
(predicate) | Difference/
Implication |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indication for Use | The Nice1 combines cold
and compression therapies.
It is intended to treat post-
surgical and acute injuries to
reduce edema, swelling, and
pain where cold and
compression are indicated.
It is intended to be used by
or on the order of a
healthcare professional in
hospital, outpatient clinics,
athletic training settings, or
home settings.
Patient population: Nice1
can be used by adults. And
children under 18 can use
the device only under the
supervision of a licensed
healthcare practitioner. | The Game Ready System
combines cold and
compression therapies. It
is intended to treat post-
surgical and acute injuries
to reduce edema, swelling, and
pain where cold and
compression are indicated.
It is intended to be used by
or on the order of a
healthcare professional in
hospitals, outpatient
clinics, athletic training
settings, or home settings.
Patient population:
Athletes and active people
and surgery patients.
Children under 18 can use
the device only under
supervision of a licensed
healthcare practitioner. | Substantially Equivalent |
| Therapy
Temperature
Range | Cool: 43°-59°F | Cool: 34°-50°F | Substantially Equivalent |
| Therapy
Mode of | Cold / Compression | Cold / Compression | Substantially Equivalent |
| | Touch screen. The different | Button, dial with display | The Nice1 uses a touch |
| Operation | control mechanism does not
affect safety and
effectiveness. | screen for user
interaction as compared
to the Game Ready
mechanical controls. | |
| Operating Fluid
Compression
Pump Pressure | Tap Water
0-75 mm Hg | Tap Water
0-75 mm Hg | Substantially Equivalent |
| Electrical Safety | AAMI ANSI ES60601-1
Electrical Safety
IEC 60601-1-2 EMC | UL 60601-1
CAN/CSA C22.2 No.
601.1
IEC 60601-1-2:2001 | Substantially Equivalent |
| Compression
Setting | Compression Off Intermittent Compression:
-High (5 to 75 mmHg).
Approximately 2 to 3
minutes of inflation and
1 minute of deflation. -Medium (5 to 50 mmHg).
Approximately 2 to 3
minutes of inflation and
1 minute of deflation. -Low (5 to 15 mmHg).
Approximately 4 to 5
minutes of inflation and 1
minute of deflation. | Compression Off Intermittent Compression:
-High (5 to 75
mmHg).
Approximately 2 to 3
minutes of inflation
and 1 minute of
deflation. -Medium (5 to 50
mmHg).
Approximately 2 to 3
minutes of inflation
and 1 minute of
deflation. -Low (5 to 15 mmHg).
Approximately 4 to 5
minutes of inflation and 1
minute of deflation. | Substantially Equivalent. |
| Knee Wrap Fit
and Dimensions | One size fits all
Length: 17"
Maximum Circumference:
Top: 32"
Bottom: 24" | One size fits all
Length: 17 3/8"
Maximum Circumference:
Top: 32"
Bottom: 24" | Substantially Equivalent. |
| Power | AC power 120V~, 50-60 Hz
DC input: 15Vdc, 12A | AC power: 100-240 V~,
50-60 Hz
DC input: 12Vdc, 2.5A | Substantially Equivalent. |
Nice Recovery Systems LLC, 1382 Kalmia Ave., Boulder, CO 80304
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Image /page/9/Picture/0 description: The image contains the logo for "nice Recovery Systems". The word "nice" is in large orange font, and the words "Recovery Systems" are in a smaller gray font below the word "nice". The logo is simple and modern.