(346 days)
The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.
Please note that the provided text is a 510(k) summary for a medical device (Explorer Mini, a pediatric powered wheelchair). It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT describe the acceptance criteria and study for an AI/ML-based medical device. It details the regulatory clearance process for a powered wheelchair, which involves proving its safety and effectiveness through engineering and human factors testing, not through AI performance metrics like sensitivity, specificity, or reader studies common for AI/ML devices.
Therefore, many of the requested points regarding AI/ML device testing (e.g., ground truth establishment, sample size for training data, MRMC studies, standalone performance) are not applicable to the information contained in this 510(k) summary.
However, I can extract the information relevant to the acceptance criteria and the studies that were performed for this specific device.
Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not relevant:
Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing" Section)
The acceptance criteria for the Explorer Mini are primarily defined by successful passage of various ISO 7176 standards, which evaluate the physical and functional characteristics of wheelchairs.
| Acceptance Criteria (ISO Standard) | Reported Device Performance (Outcome) |
|---|---|
| ISO 7176-1:2014 - Determination of static stability | Pass |
| ISO 7176-2:2001 - Determination of dynamic stability of electric wheelchairs | Pass |
| ISO 7176-3:2012 - Determination of effectiveness of brakes | Pass |
| ISO 7176-4:2008 - Energy consumption for determination of theoretical distance range | Pass |
| ISO 7176-5:2008 - Determination of overall dimensions, mass and maneuvering space | Pass |
| ISO 7176-6:2001 - Determination of maximum speed, acceleration and deceleration | Pass |
| ISO 7176-7:1998 - Measurement of seating and wheel dimensions | Pass |
| ISO 7176-8:2014 - Requirements and test methods for static, impact and fatigue strengths | Partial conformance (alternative evidence provided) |
| ISO 7176-9:2009 - Climatic tests for electric wheelchairs | Pass |
| ISO 7176-10:2008 - Determination of obstacle-climbing ability of electrically powered wheelchairs | Pass |
| ISO 7176-14:2008 - Power and control systems for electrically powered wheelchairs and scooters | Pass |
| ISO 7176-15:1996 - Requirements for information disclosure, documentation and labeling | Pass |
| ISO 7176-16:2012 - Resistance to ignition of postural support devices | Pass |
| ISO 7176-21:2009 - Electromagnetic compatibility | Pass |
| ISO 7176-25:2013 - Batteries and chargers for powered wheelchairs | Partial conformance (alternative evidence provided) |
| RESNA WC-1:2009 Section 20 - Determination of the Performance of Stand-up Type Wheelchairs | Pass |
| ISO 10993-1 - Biological evaluation of medical devices | Pass |
Study Details:
-
Sample size used for the test set and the data provenance:
- Non-Clinical Testing: The document refers to "the Explorer Mini" being tested according to the ISO standards. This implies testing of the device itself, likely multiple units for robustness, rather than a "test set" in the sense of patient data for an AI algorithm. The provenance is implied to be from the manufacturer's testing facilities based on compliance with international standards. Details like number of devices tested or specific test runs are not provided.
- Clinical Testing (Usability Study): 33 children with mobility impairments were included. This was a usability study, not a clinical trial to prove efficacy in the traditional sense, but focused on how users interact with the device.
- Clinical Testing (Label Comprehension Study): 15 physiotherapists/occupational therapists and 15 parents participated.
- Data Provenance: Not explicitly stated (e.g., country of origin for the usability study participants), but the studies were conducted by the manufacturer Permobil AB (Sweden). The studies appear to be
- Usability Study: Prospective, as it involved real children interacting with the device.
- Label Comprehension Study: Prospective, as it involved participants reviewing the user manual.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the traditional AI sense. For a physical device like a wheelchair, "ground truth" is established by direct measurement against engineering standards and specifications (e.g., speed, dimensions, stability tests). The experts involved would be engineers, technicians, and potentially clinical professionals ensuring the device meets the needs of pediatric users.
- For the Usability Study, the "ground truth" would be observed user behavior and feedback, assessed by human factors engineers/clinicians.
- For the Label Comprehension Study, the "ground truth" was whether participants could correctly understand the label, assessed by the study design and interpretation of responses from "physiotherapists/occupational therapists and parents." Their qualifications are stated by their profession.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is an AI/ML specific term for resolving discrepancies in expert labeling. For physical device performance tests (ISO standards), the results are typically objectively measured and don't require expert adjudication in the same way. For the usability/label comprehension studies, detailed adjudication methods are not provided, but such studies typically involve qualitative and quantitative analysis of user interactions and feedback.
-
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 is specific to AI/ML devices where AI assists human interpretation (e.g., radiologists reading images). This product is a physical mobility device and does not involve AI assistance for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is an AI/ML specific concept. The device's performance is inherently tied to its physical interaction with a user ("human-in-the-loop" is a given for a wheelchair).
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Non-Clinical Testing: Engineering specifications and standardized test methods (ISO 7176 series). The "ground truth" is adherence to these defined performance benchmarks.
- Clinical Testing (Usability/Label Comprehension): User behavior, performance, and understanding as observed and measured through structured studies.
-
The sample size for the training set:
- Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 7).
In summary, the provided document outlines the process for clearance of a physical medical device (a pediatric powered wheelchair) by demonstrating its safety and effectiveness through compliance with recognized international standards for wheelchairs and human factors studies. It does not pertain to the development or validation of an AI/ML diagnostic or assistive algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
February 27, 2020
Permobil AB Ivan Fernandez Director of Regulatory Compliance Box 120 S-861 23 Timra, Sweden
Re: K190682
Trade/Device Name: Explorer Mini Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: January 28, 2020 Received: January 28, 2020
Dear Ivan Fernandez:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K190682
Device Name
Explorer Mini
Indications for Use (Describe)
The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K190682
| Submitter | Permobil ABBox 120S-861 23 TimråSweden |
|---|---|
| Phone:Facsimile: | +46 60 595900+46 60 575250 |
| Contact Person: | Ivan Fernandez, Director of Regulatory Compliance |
| Email Address: | ivan.fernandez@permobil.com |
| Telephone number: | 800-736-0925 |
| Date Prepared: | February, 2020 |
| Trade Name: | Explorer Mini |
| Common/Classification Name: | Wheelchair, Standup,Standup Wheelchair |
| Product Code: | IPL21CFR 380.3900 |
| Predicate Device: | WHEELCHAIR MODEL STSInnovative Products Inc071390Product code: IPL21CFR 380.3900 |
Description of the Explorer Mini
This submission covers the Explorer Mini device.
Indication for use:
The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
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General Description:
The Explorer Mini is designed for children with mobility impairments that will never walk, inefficient mobility or lose the ability to walk efficiently, need mobility assistance in early childhood.
The Explorer Mini is intended for children weighing up to 35 pounds versus the Wheelchair Model STS (K071390) which is intended for users weighing up to 150 pounds. The Explorer Mini is designed specifically for the pediatric users. This is a limit in indications for use to the larger population of the predicate device that includes children and young adults. Clinical and non-clinical performance testing has demonstrated this difference does not affectiveness of the device when used as labeled.
Use environment:
Explorer Mini is intended to be used in everyday life, in safe environments where the child is. Typical environments are at the clinical training site, at home, at preschool, at friends and extended family. The design of the device is small and compact, making it possible for the child to drive the device in these environments.
Like any other infant or toddler at play, Explorer Mini is intended to be used under supervision by an adult, and it is the care-givers responsibility to ensure that the surrounding environment is safe and appropriate for the child to drive.
Principle of operation:
Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column.
The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick.
The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Both appearance and weight are factors critical to acceptance by the intended user population.
Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving.
The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles.
The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module.
When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.
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Predicate comparison of major technical features:
The Explorer Mini is substantially equivalent to WHEELCHAIR MODEL STS (Innovative Products Inc., K071390, product code: IPL). The Explorer Mini has similar intended use and indications, technological characteristics, and principles of operation. The differences between the Explorer Mini and the predicate device are:
- The total weight of the of the device is considerably less at 40 pounds. This make the Explorer Mini easier to handle for secondary users.
- The speed of the Explorer Mini is 1.5mph while the Wheelchair Model STS (K071390) has a speed of up to 5mph. The speed is set to correlate to the speed a child within the intended age has when or running slowly. The low speed also ensures that the caregiver can keep up with child. This ensures that Explorer Mini has a safer speed for the pediatric end user as well as care giver.
The minor technological differences between Explorer Mini and its Predicate device Wheelchair Model STS raise no new issues of safety or effectiveness. Performance data demonstrates that the Explorer Mini is as safe and effective as the Wheelchair Model STS. Thus, the Explorer Mini is substantially equivalent.
Table 1 provides a comparison of the predicate device (Wheelchair Model STS) and the Explorer Mini in order to demonstrate substantial equivalence.
| Feature | Predicate Device: | Subject Device: | Comparison |
|---|---|---|---|
| Wheelchair Model STS | Explorer Mini | ||
| 510(k) number | K071390 | K190682 | N/A |
| Intended Use | The intended use of the modelSTS pediatric poweredwheelchair is to providemobility to children andyoung adults, weighting up to150 pounds, with the ability toplace themselves in a sittingposition in the wheelchair andhave the capacity to operate astandard joy stick handcontrol. | The Explorer Mini isa pediatric poweredwheelchair with theintention to providemobility to pediatricusers weighing up to35 pounds andmaximum length ofup to 39 inches tall,between 12-36months of age, whoposition themselvesin a sitting position inthe wheelchair andhave the capacity tooperate a joy stick | Permobil has designedthe Explorer Minispecifically for thepediatric usersweighing up to 35pounds andmaximum length ofup to 39 inches tall,between 12-36months of age, whichis a narrower scope ofthe predicate device.The predicate devicehas a broader targetgroup "…providemobility to children |
| weighting up to 150pounds...”. Several ofthe functions in theExplorer Mini aredesigned to beappropriate for theyoung target group,such as the lowerspeed, seating area,table area, etc. | |||
| Product code | IPL 890.3900 | IPL 890.3900 | Identical |
| User age rangesand maximumweightcapacities | Children or young adultsweight up to 150 lbs. | 12-36 months -35lbs(16kg) or 39”(100cm) | Differences is thatSTS does specifyupper weight limit butdoes not specifyintended user agepopulation. Theintended user ofExplorer Mini isdescribed by a lowerage limit and amaximum weight andphysical size limit.Regardless of userweight or age, no newor increased risks areidentified. TheExplorer Mini hasbeen subjected to allapplicable ISO 7176series tests |
| Devicedescription | STS includes a base to whichthe wheels and casters areattached with the option ofattaching a seat or standingframe. | Explorer Minipowered wheelchairincludes a base towhich wheels andcasters are attachedwith the option ofutilizing the seat orconfiguring thesystem for standing | FunctionallyEquivalent |
| When the joystick is activateda signal is directed through thepower module to the gearmotors which propel the chair | When the joystick isactivated a signal isdirected through thepower module to thegear motors whichpropel the chair | Identical | |
| & control both speed and direction | control both speed and direction | ||
| STS uses a motor lock systemfor park brakes. A park brakefor safety is attached to eachgear-motor which is activatedwhen the chair comes to a stop | A park brake isprovided by the gearratio which isdesigned to preventmovement when nosignal is detected. | FunctionallyEquivalent | |
| Total width | 24" | 19" | FunctionallyEquivalent |
| Total length | 32" | 25" | FunctionallyEquivalent |
| Total height | 35" (to backrest) | Minimum: 28.7"Maximum 36.6" | FunctionallyEquivalent |
| Turningdiameter | 50" | 42.5" | FunctionallyEquivalent |
| Speed Range | 0-5 mph | 0-1.5 mph | Appropriate for theintended user group |
| Driving range | 25 miles | 3.4 miles | Appropriate for theintended user group |
| Brake distance-Normaloperation(Horizontal-Forward-Maxspeed) | Information regarding thebraking distance for the STSis not available in the labeling | Minimum brakingdistance frommaximum speed11.8" | The lower speed of theExplorer Mini and thegear ratio which isdesigned to preventmovement when nosignal is detected, andthereby ensuring that |
| Time to brake | Information regarding thebraking distance for the STShas not been found. The STSUser Manual states:The STS is equipped with twopowerful brake systems.• Regenerative – useselectricity to rapidlyslow the vehicle whenthe joystick returns tothe center/stopposition.• Disc park brake –activates mechanicallyafter regenerativebraking slows the | A park brake isprovided by the gearratio which isdesigned to preventmovement when nosignal is detected.When the userreleases the joystick,the chair immediatelydecelerates to a stop. | the Explorer Ministops immediatelymake the ExplorerMini safer than theSTS in regard tobraking distance |
| or when power isremoved from thesystem for any reasonThe STS uses a motor locksystem for park brakes. A parkbrake for safety is attached toeach gear-motor which isactivated when the chaircomes to a stop. | |||
| Operatingsurface &environment | The STS is designed tooperate both indoors andoutdoors. It maneuvers on allterrains except soft sand. | Explorer Mini isdesigned for indooruse and limitedoutdoor use on firm,flat and dry surfaces | Explorer Mini isintended to be used onsafersurfaces/surroundings.Even though theExplorer Mini isdesigned for limitedoutdoor use it hasbeen subjected to thesame stability testrequirements as anoutdoor chair. |
| Manageablegradient | 5° | 6° | FunctionallyEquivalent |
| Max. curb heightObstacleClimbing Ability | 2.5" | 1.0" | Appropriate for theintended useenvironment |
| Max. chairweight | 160 lbs. | 52 lbs. | Appropriate for theintended user group |
| Frame material,frame tube size | The STS is constructedprimarily of steel tubing. Thebase has a steel frame with amolded Plastic Overlay. Theseat and standing frame areconstructed of steel tubing. Aversion of the standing systemuses a wooden backboard. | The Explorer Minibase is constructedwith a steel framewith molded PlasticOverlays. The toweris constructed withaluminum extrusionswhile the seat andtable are acombination ofaluminum and steelcomponents withmolded plasticoverlays. The backand lateral arms aremolded plastic | There are differencesin the materials usedbut both products areappropriatelyconstructed for theintended user and theintended useenvironment and hasbeen tested accordingto the requirementsand to ensure safety ofthe device. TheExplorer Mini hasbeen tested per ISO7176 testrequirements. No newrisk identified. Both |
| Mini are appropriatelyconstructed for theintended use | |||
| Controller | Controller 24V PG | Controller 24V PG nVR2 | Functionally Equivalent |
| Joystick mounting | Left or right mounted | Central mounted | Functionally Equivalent |
| Batteries | 2 x 28 AH Gel cell batteries | 2 x 12 V AGM lead-acid batteries in series | Functionally Equivalent |
| Stand-up feature | Power to go from sit to stand | Manual adjustment to go from sit to stand | Functionally Equivalent |
Table 1 Comparison to predicate device
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Image /page/9/Picture/0 description: The image shows the word "permobil" in blue font. The font is sans-serif and the letters are all lowercase. The word is slightly italicized, and the "o" is smaller than the other letters. The background is white.
Non-Clinical Testing:
The Explorer Mini has been tested according to ISO 7176 evaluates the strength, stability (static and dynamic), and durability of the powered wheelchair. Tests are performed on the whole wheelchair to determine the performance, safety, and effectiveness of the device. All performed testing revealed that the Explorer Mini successfully passed all requirements and was found to be substantially equivalent to the predicate device mentioned in this submission.
The predicate device, the STS device, was tested according to FDA Recognized standards. The Explorer Mini was tested to the current recognized standards; ISO 7176 Series.
| Recognized standard | Standard name | Outcome |
|---|---|---|
| ISO 7176-1:2014[ANSI/RESNA WC-1/1] | Wheelchairs - Part 1: Determination of static stability | Pass |
| ISO 7176-2:2001[ANSI/RESNA WC-1/1] | Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Pass |
| ISO 7176-3:2012[ANSI/RESNA WC-2/3] | Wheelchairs - Part 3: Determination of effectiveness of brakes | Pass |
| ISO 7176-4:2008[ANSI/RESNA WC-2/4] | Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Pass |
| ISO 7176-5:2008[ANSI/RESNA WC-1/5] | Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space | Pass |
| ISO 7176-6:2001[ANSI/RESNA WC-2/6] | Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Pass |
| ISO 7176-7:1998[ANSI/RESNA WC-1/7] | Wheelchairs - Part 7: Measurement of seating andwheel dimensions | Pass |
| ISO 7176-8:2014[ANSI/RESNA WC-1/8] | Wheelchairs - Part 8: Requirements and testmethods for static, impact and fatigue strengths | Partialconformanceprovidedalternativeevidence to fulfillrequirement |
| ISO 7176-9:2009[ANSI/RESNA WC-2/9] | Wheelchairs - Part 9: Climatic tests for electricwheelchairs | Pass |
| ISO 7176-11:2012 | Wheelchairs - Part 11: Test dummies | N/A - Thisstandard setsrequirements fortesting |
| ISO 7176-10:2008[ANSI/RESNA WC-2/10] | Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically poweredwheelchairs | Pass |
| ISO 7176-13:1989 | Wheelchairs - Part 13: Determination ofcoefficient of friction of test surfaces | N/A - Thisstandard setsrequirements fortesting |
| ISO 7176-14:2008[ANSI/RESNA WC-2/14] | Wheelchairs - Part 14: Power and control systemsfor electrically powered wheelchairs and scooters -Requirements and test methods | Pass |
| ISO 7176-15:1996[ANSI/RESNA WC-1/15] | Wheelchairs - Part 15: Requirements forinformation disclosure, documentation andlabeling | Pass |
| ISO 7176-16:2012[ANSI/RESNA WC-1/16] | Wheelchairs - Part 16: Resistance to ignition ofpostural support devices | Pass |
| ISO 7176-21:2009[ANSI/RESNA WC-2/21] | Wheelchairs - Part 21: Requirements and testmethods for electromagnetic compatibility ofelectrically powered wheelchairs and scooters, andbattery chargers | Pass |
| ISO 7176-25:2013 | Wheelchairs - Part 25: Batteries and chargers forpowered wheelchairs | Partialconformanceprovidedalternativeevidence to fulfillrequirement |
| RESNA WC-1:2009Section 20 | Determination of the Performance of Stand-upType Wheelchairs | Pass |
| ISO 10993-1 | Biological evaluation of medical devices | Pass |
Table 2 List of recognized standards to which the Explorer Mini complies
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Image /page/11/Picture/1 description: The image shows the word "permobil" in a sans-serif font. The word is written in all lowercase letters and is a dark blue color. The letters are closely spaced together, giving the word a compact appearance.
Clinical Testing:
The device is designed to provide the compensatory motor skills that work in concert with the sensory skills to bring about postural control, upper extremity stability in this young population where several developmental milestones remain to be met. A usability study was performed on 33 children with mobility impairments justifying a need for a device as the Explorer Mini. A label comprehension study of the User's manual was performed on 15 physiotherapists/occupational therapists and 15 parents. The human factor validation testing revealed that the Explorer Mini is a safe and effective medical device for the intended user, and all studied use-related risks were deemed acceptable.
Conclusions:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as the legally marketed device. The Explorer Mini and Predicate device, Wheelchair Model STS are substantially equivalent. Explorer Mini has the same general intended use and similar indications, principles of operation, and similar technological characteristics as the previously cleared WHEELCHAIR MODEL STS; Innovative Products Inc
- K071390 ●
- Product code: IPL
- 21CFR 380.3900
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).