AMP by Method Mobility, AMP Plus (or +) by Method Mobility
Device Facts
| Record ID | K231032 |
|---|---|
| Device Name | AMP by Method Mobility, AMP Plus (or +) by Method Mobility |
| Applicant | Method Mobility |
| Product Code | ITI · Physical Medicine |
| Decision Date | May 10, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Intended Use
The AMP by Method Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
Device Story
AMP by Method Mobility and AMP Plus are power-assist devices designed to attach to manual wheelchairs; provides powered mobility to users capable of operating both manual and powered wheelchairs. Device transforms manual wheelchairs into powered mobility solutions; intended for use by individuals with disabilities to enhance mobility. Operated by the user; provides motorized propulsion to assist with navigation. Benefits include increased independence and mobility for patients requiring powered assistance in daily activities.
Technological Characteristics
Powered wheelchair accessory (21 CFR 890.3860, Product Code ITI).
Indications for Use
Indicated for disabled persons capable of operating a powered and manual wheelchair requiring powered mobility assistance for manual wheelchairs.
Regulatory Classification
Identification
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Related Devices
- K113621 — SMARTDRIVE WHEELCHAIR POWER-ASSIST · Max Mobility, LLC · Jul 6, 2012
- K151199 — SmartDrive Wheelchair Power Assist · Max Mobility, LLC · Jul 30, 2015
- K161241 — e-fix E35/E36 · Alber GmbH · Oct 5, 2016
- K220213 — Empulse R90 · Sunrise Medical (Us), LLC · Mar 30, 2022
- K982066 — MP-3 POWER BASE CHAIR · Merits Health Products., Inc. · Aug 31, 1998
Submission Summary (Full Text)
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May 10, 2023
Method Mobility % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K231032
Trade/Device Name: AMP by Method Mobility, AMP Plus (or +) by Method Mobility Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 9, 2023 Received: April 11, 2023
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
## Tushar Bansal -S
Tushar Bansal, PhD Acting 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
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## Indications for Use
510(k) Number (if known) K231032
Device Name
AMP by Method Mobility, AMP Plus (or +) by Method Mobility
Indications for Use (Describe)
The AMP by Method Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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