X-CHANGE
Device Facts
| Record ID | K051090 |
|---|---|
| Device Name | X-CHANGE |
| Applicant | Meyra |
| Product Code | IOR · Physical Medicine |
| Decision Date | May 13, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The X-Change wheelchair family is designed mostly for adults in the use of a device to assist them with their mobility needs.
Device Story
X-Change is a mechanical wheelchair designed to assist adults with mobility needs. Device functions as a manual mobility aid; operated by the user or a caregiver. Provides physical support and transport for individuals with limited mobility. No complex electronics, software, or automated algorithms involved.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Mechanical wheelchair; manual operation. No energy source, software, or electronic components. Materials and construction consistent with standard manual wheelchair design.
Indications for Use
Indicated for adults requiring assistance with mobility needs.
Regulatory Classification
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Submission Summary (Full Text)
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MAY 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEYRA C/o Mr. Kirk MacKenzie Snug Seat Incorporated 12801 East Independence Boulevard Matthews, North Carolina 28106
Re: K051090 Trade/Device Name: X-Change Regulation Number: 21CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: February 28, 2005 Received: April 28, 2005
Dear Mr. MacKenzie:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becement in (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is atgrand ment date of the Medical Device Amendments, or to conniered prior to May 2017, 11:37 accordance with the provisions of the Federal Food, Drug, de necs may been revire approval of a premarket approval of a premarket approval application (PMA). and Cosmetic Free (110. (110.) that be vice, subject to the general controls provisions of the Act. The I ou may, mererore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 your acviec is elaboried (600 ac c) controls. Existing major regulations affecting your device n may be subject to saal additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oodous ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Dri 3 lisualited on a vice complies with other requirements of the Act that IDA has made a decornmansir an administered by other Federal agencies. You must of any it catal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act 31equirements, newsg, and manufacturing practice requirements as set CFK Fall 807), ademig (21 OF R Part 820); and if applicable, the electronic (200 1000 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Kirk MacKenzie
This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to ocgin maing of substantial equivalence of your device to a legally premarket notification: "The PDs 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 If you desire specific at not 10 - 1 - 2 - 240) 276-0120 . Also, please note the regulation entitled, Contider the Office or Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Hyatt Hurdle
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## INDICATIONS FOR USE
ﭘﻮ
510(k) Number:
Device Name:
X-Change
K. Q51090
Indications for Use:
The X-Change wheelchair family is designed mostly for adults The X-Change wheelehall family to esolgion in the use of a device to assist them with their mobility needs.
Prescription Use (Part 21 CFR 801 Subpart D)
.
x
AND/OR
Over-The-Counter Use > (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Rurdu
(Division Sign-C Division of General, Restorative, and Neurological Devices
KOSIO90 510(k) Number_________________________________________________________________________________________________________________________________________________________________
