← Product Code [IMK](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMK) · K210920
# iBOT Personal Mobility Device (iBOT PMD) (K210920)
_Mobius Mobility · IMK · Jun 16, 2021 · Physical Medicine · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMK/K210920
## Device Facts
- **Applicant:** Mobius Mobility
- **Product Code:** [IMK](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMK.md)
- **Decision Date:** Jun 16, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3890
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic
## Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair.
## Device Story
iBOT® PMD is a multi-mode powered wheelchair for indoor/outdoor mobility; enables stair climbing, curb traversal, and obstacle navigation. Input: user commands via joystick/controller; internal MEMS sensors/absolute position sensors monitor orientation/stability. Operation: active stabilization system maintains balance in various modes (Standard, 4-Wheel, Balance, Stair-climbing, Remote, Docking). Output: powered movement; elevated seat height for daily living activities. Used in home/community settings; operated by patient or trained companion. Healthcare providers use device to facilitate mobility/independence. Benefits: improved accessibility, eye-level interaction, and safe occupied transport in motor vehicles. Updates from predicate include helical gear train for noise reduction, redesigned brake release, and occupied transport capability compliant with ISO 7176-19.
## Clinical Evidence
Bench testing only. Compliance demonstrated with ISO 7176 series (stability, brakes, energy consumption, dimensions, speed, fatigue, obstacle climbing, power/control systems, electromagnetic compatibility, stair-climbing), IEC 62133 (batteries), ISO 10993 (biocompatibility), and UL 2054. Usability testing conducted for docking mode and occupied transport interfaces. No clinical data presented.
## Technological Characteristics
Powered wheelchair with active stabilization; MEMS-based inertial measurement; CAN bus communication; Bluetooth 4.2 LE. Helical gear train. Four or six 57.6 VDC Li-ion batteries. Max speed 6.7 mph. Dimensions/stability per ISO 7176 standards. Software-controlled modes. Occupied transport compliant with ISO 7176-19.
## Regulatory Identification
A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.
## Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
(i) Fatigue testing;
(ii) Resistance to dynamic loads (impact testing);
(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
(3) The skin-contacting components of the device must be demonstrated to be biocompatible.
(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(6) Performance testing must demonstrate battery safety and evaluate longevity.
(7) Performance testing must evaluate the flammability of device components.
(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device and the principles of how the device works;
(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
(iii) Preventive maintenance recommendations;
(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
(v) A detailed summary of the device-related adverse events and how to report any complications.
(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:
(i) Identification of patients who can effectively operate the device; and
(ii) Instructions on how to fit, modify, or calibrate the device.
(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.
## Predicate Devices
- Next Generation iBOT® ([K172601](/device/K172601.md))
## Reference Devices
- Permobil F5 Corpus VS ([K191874](/device/K191874.md))
## Submission Summary (Full Text)
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June 16, 2021
Mobius Mobility Joseph Sullivan QA / RA Manager 540 Commercial St. Suite 310 Manchester, New Hampshire 03101
Re: K210920
Trade/Device Name: iBOT® Personal Mobility Device ("iBOT® PMD") Regulation Number: 21 CFR 890.3890 Regulation Name: Stair-Climbing Wheelchair Regulatory Class: Class II Product Code: IMK, ITI Dated: March 25, 2021 Received: March 29, 2021
Dear Mr. Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
For Heather Dean, PhD Assistant Director, Acute Injury 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K210920
#### Device Name
iBOT® Personal Mobility Device (iBOT® PMD)
#### Indications for Use (Describe)
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair.
Type of Use (*Select one or both, as applicable*)
| | |
|--|--------------------------------------------------------------------------------------------------------|
| | |
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# 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.
### Date Prepared: March 22, 2021
# Submitter's Information
| 510(k) Sponsor: | Mobius Mobility 540 North Commercial Street Suite 310 Manchester, NH 03101 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Sullivan QA / RA Manager Mobius Mobility Phone: (833) 346-4268 Fax: (603) 621-0789 jsullivan@mobiusmobility.com |
## Device Information
| Common/Usual Name: | Stair-climbing wheelchair |
|---------------------------------------|----------------------------------------------|
| Trade/Proprietary Name: | iBOT® Personal Mobility Device ("iBOT® PMD") |
| Classification Name: | Stair-climbing wheelchair |
| Device Classification: | 890.3890 |
| 2nd Device Classification: | 890.3860 |
| Primary Product Code (stair feature): | IMK |
| Secondary Product Code: | ITI |
| Device Panel: | Physical Medicine |
## Predicate Device(s)
The iBOT® PMD is substantially equivalent to the Next Generation iBOT®, which was previously cleared under 510(k) #K172601.
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## Reference Device
Permobil F5 Corpus VS (K191874).
### Device Description
The proposed device is an update to the previously cleared device Next Generation iBOT® (K172601). The device retains all the following from the original device including:
The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.
The device still includes active stabilization in modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g. accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.
The proposed device still utilizes the primary components of a stair climbing power wheels, frame, sealed electronics, sensors, battery packs, motors, seative stability system and battery charger. It can also be produced without the stair climbing function.
In addition, the device will incorporate the following updates to the Next Generation iBOT® design:
- Allows for occupied transportation in a motor vehicle ●
- Incorporates the use of an alternate seating system, mounting and peripherals ●
- . Wheel gear train changed from spur to helical
- Redesigned brake release lever mechanism
- Changes of materials / processes in support of Design for Manufacturing efforts .
- Software revisions / changes ●
- Incorporates change of the Trade name to iBOT® PMD ●
- Updates contraindications to increase clarity ●
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# Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the uses ment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat. the option for transportation while seated in their iBOT® PMD wheelchair.
### Comparison to Predicate Device and Reference Device
The proposed device has similar technological characteristics and mobility functions as compared to the design modifications were done to do the following:
- Add indication for use as a seat in a motor vehicle .
- Take advantage of improvements in technology since the Next Generation iBOT® was originally cleared .
Where appropriate, component design has been maintained from the Next Generation iBOT®. The overall system and fundamental technology from the Next Generation iBOT® has been maintained.
The reference device was chosen to demonstrate substantial equivalence for the following components and features on the device:
- · Occupied Transportation Options
- · Power Wheelchair Seating System cleared for use in a motor vehicle
The first table below shows the similaries and differences between the proposed devices. The second table below shows the similarities and differences between the reference and proposed modifications from the predicate device or reference devices do not raise new questions regarding safety or effectiveness of the device.
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# Table of Comparisons from Predicate Device to Proposed Device
| Characteristic | Predicate Device (Next Generation iBOT®) (K172601) | Proposed (iBOT® PMD) | Assessment of difference (if applicable) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Characteristics | | |
| Indications for Use | The Next Generation iBOT® is intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device is intended to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. | The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair. | The modifications to the Indications for Use to make the stair-climbing functions optional and to add the (optional) Occupied Transport capability do not constitute a new intended use and do not introduce new issues of safety and effectiveness. |
| Manufacturer | DEKA Research & Development | Mobius Mobility, LLC | Product continues to be designed by DEKA and is now distributed by Mobius Mobility. |
| Product Code | IMK | IMK, ITI | No product difference, applying for additional code for non-stair climbing version |
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| Characteristic | Predicate Device (Next Generation iBOT®) (K172601) | Proposed (iBOT® PMD) | Assessment of difference (if applicable) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Contraindications | • Weigh less than 50 lbs. (22.5 kg) or more than 300 lbs. (136kg) • Have lost consciousness or had a seizure in the past 90 days (there are some exceptions, ask your clinician for details) • Have a condition where jarring forces could cause fractures • Have not successfully completed the user training program • Need a mechanical ventilator | • Weigh less than 50 lbs. (22.5 kg) or more than 300 lbs. (136kg) • Are at risk for seizure or loss of consciousness. • Are at risk of fracture while driving over rough terrain or while experiencing jarring forces related to rapid iBOT® PMD transitions. • Have not successfully completed the user training program • Need a mechanical ventilator | Wording updated for clarity. No new risks identified. |
| Physical Characteristics | | | |
| Drive wheel type | Pneumatic or foam-filled. 5 bolt pattern, split rim design. | Pneumatic or foam-filled. 5 bolt pattern, split rim design. | No change |
| Caster assembly | Standard caster wheel with suspension assembly | Standard caster wheel with suspension assembly | No change |
| Batteries | Four or Six Li-ion batteries, each rated 57.6 VDC, 5.1 Ah | Four or Six Li-ion batteries, each rated 57.6 VDC, 5.1 Ah | No change |
| Characteristic | Predicate Device (Next Generation iBOT®) (K172601) | Proposed (iBOT® PMD) | Assessment of difference (if applicable) |
| Physical Characteristics | | | |
| Communication with external applications/devices | Bluetooth 4.2 Low Energy | Bluetooth 4.2 Low Energy | No change |
| Drive system | Rear wheel drive, 4-wheel drive, 2-wheel balancing | Rear wheel drive, 4-wheel drive, 2-wheel balancing | No change |
| Operating modes | Standard, 4-Wheel, Balance, Stair-climbing, Remote | Standard, 4-Wheel, Balance, Stair-climbing, Remote, Docking | One additional mode option (docking) available. Design follows structure for other modes available in the controller and does not involve additional safety risk. Confirmation done through human factors testing to ensure no new risks emerged in use. |
| Inertial Measurement | MEMS based sensors | MEMS based sensors | No change |
| Wheel gear train | Spur Gear | Helical Gear | Gear changed to reduce drive noise. No new risks identified. |
| Position monitoring | Internal absolute position sensor | Internal absolute position sensor | No change |
| System Communication | CAN bus | CAN bus | No change |
| Weight (including batteries) | 242.5 lb. | 242.5 lb. | No change |
| Device Performance | | | |
| Driving Range | 15.5 miles | 15.5 miles | No change |
| Characteristic | Predicate Device (Next Generation iBOT®) (K172601) | Proposed (iBOT® PMD) | Assessment of difference (if applicable) |
| Device Performance | | | |
| Dynamic stability | 10 degrees (standard) 12 degrees (4 wheel) 8 degrees (balance) | 10 degrees (standard) 12 degrees (4 wheel) 8 degrees (balance) | No change |
| Max Speed Settings by Mode | Standard: 6.7 mph 4-Wheel: 5.2 mph Balance: 3.3 mph | Standard: 6.7 mph 4-Wheel: 5.1 mph Balance: 3.5 mph Docking: 0.6 mph | Docking mode added. |
| Maximum user weight capacity | 300 lb. | 300 lb. | No change |
| Obstacle Climbing | 5 in. (in 4 wheel mode) | 5 in. (in 4 wheel mode) | No change |
| Turning Radius | 24.5 in. – 33.8 in. (dependent on mode) | 24.5 in. – 33.8 in. (dependent on mode) | No change |
| User Interface Features | | | |
| Seating | Gen 3 Seat | Maxx Rehab Seat | Equivalent in: ● Safety features ● General design ● Standards met ● Seat angles ● Movement, including angles and heights They differ in: ● Modularity ● Seat Interface ● Peripherals ● Stair Assist Handle ● Available seat sizes |
| Characteristic | Predicate Device (Next Generation iBOT®) (K172601) | Proposed (iBOT® PMD) | Assessment of difference (if applicable) |
| User Interface Features | | | |
| User controller, joystick, screen, buttons, etc. | User controller with integrated joystick, display, buttons, speed setting reduction wheel, and optional toggle switches. The user controller incorporates user assist confirmation. Power off request button located on the powerbase. | User controller with integrated joystick, display, buttons, speed setting reduction wheel, and optional toggle switches. The user controller incorporates user assist confirmation. Power off request button located on the powerbase. | No change |
| Transportation | Unoccupied Transport Option | Unoccupied Transport Option Occupied Transport Options | Equivalent in: Both have 4 tie down loops to secure device in vehicle Differences: Testing done to allow tie down loops to be used while device is occupied in vehicle Interface to docking system added to allow alternate method of securing occupied device in vehicle Occupied Transport version complies with ISO 7176-19. Risks specific to the occupied transport option were identified via FMEA. All risk mitigations were successfully verified/validated with no impact to safety or effectiveness of the device. |
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# Table of Comparisons from Predicate Device to Proposed Device
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# Table of Comparisons from Reference Device to Proposed Device
| Characteristic | Reference (Permobil F5 Corpus VS) (K191874) | Proposed (iBOT® PMD) | | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| General Characteristics | | | | |
| Indications for Use | The F5 Corpus VS powered wheelchair is to provide indoor and outdoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair. | The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is intended to provide persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair. | | |
| Product Code | IPL, ITI | IMK, ITI | | |
| Physical Characteristics | | | | |
| Drive wheel type | Pneumatic or foam-filled. | Pneumatic or foam-filled. | | |
| Caster assembly | Standard caster wheel with suspension assembly | Standard caster wheel with suspension assembly | | |
| Batteries | 2 x 12V 73 Ah gel Group M24 | Four or Six Li-ion batteries, each rated 57.6 VDC, 5.1 Ah | | |
| Communication with external applications/devices | Bluetooth | Bluetooth | | |
| Drive system | Front wheel drive, standing | Rear wheel drive, 4-wheel drive, 2-wheel balancing | | |
| Characteristic | Reference (Permobil F5 Corpus VS) (K191874) | Proposed (iBOT® PMD) | | |
| Operating modes | Standard, Stand-Up…
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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMK/K210920](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IMK/K210920)
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