(67 days)
The Multilift Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.
The Multilift is similar to other products in commercial distribution. These products, like the Multilift, utilize electrically driven, wall-mounted on self-standing platform units to enable individuals in wheelchairs to travel up and down between floors in a residential or public setting.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth.
The document is a 510(k) summary for a vertical platform lift (Multilift) and focuses on establishing substantial equivalence to a predicate device (Savaria V-1504 Vertical Platform Lift). It primarily discusses the device's description, intended use, and comparison to the predicate, as well as the FDA's regulatory decision. It does not contain details of a performance study or testing that would typically address the criteria you've outlined.
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510(k) SUMMARY
MAR 0 4 2003
| Submitted by: | Barnes, Richardson & Colburn1225 Eye Street, N.W.Washington, D.C. 20005 |
|---|---|
| Contact: Stephen W. BrophyTel: (202) 457-0300 | |
| Date Prepared: | December 16, 2002 |
| Subject Device: | Savaria Mult-lift |
| Predicate Device: | Savaria V-1504 Vertical Platform Lift(K960739). |
| Subject ProductDescription: | The Multilift is similar to other products in commercial distribution.These products, like the Multilift, utilize electrically driven, wall-mountedon self-standing platform units to enable individuals in wheelchairs totravel up and down between floors in a residential or public setting. Seeattached product information on Savaria's V-1504 Vertical Platform Lift(K960739). |
| Intended Use: | The Multilift is intended to mechanically transport an individual in awheelchair directly between floors in a private residence. |
| ProductComparison: | The Multilift is substantially equivalent in design and function to Savaria'sV-1504 Vertical Platform Lift (K960739). Also of steel construction, theV-1504 lift uses principally the same design as the Multi-lift. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Services Industriels Savaria, Inc. c/o Mr. Stephen W. Brophy Barnes, Richardson & Colburn 1225 Eye Street, N.W., Suite 1150 Washington, DC 20005
Re: K024346
Trade/Device Name: Multilift: Vertical Platform Lift Regulation Number: 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: February 5, 2003 Received: February 5, 2003
Dear Mr. Brophy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.
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Page 2 - Mr. Stephen W. Brophy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark M. Millerms
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN) : i (O24346
DEVICE NAME : Multilift: Vertical Platform Lift
INDICATIONS FOR USE:
The Multilift Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1)
Mark A. Miller
- Restorative revices 18000 222 322 2012
§ 890.3930 Wheelchair elevator.
(a)
Permanently mounted wheelchair platform lift —(1)Identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair.(2)
Classification. Class II. The permanently mounted wheelchair platform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.
(b)
Portable wheelchair elevators —(1)Identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).(2)
Classification. Class II.