(63 days)
Not Found
No
The device description details a standard mechanical wheelchair with no mention of AI or ML components or functionalities.
No
A therapeutic device is used to treat or prevent a medical condition. A wheelchair provides mobility support but does not directly treat or prevent a medical condition.
No
Explanation: The device description states it is a wheelchair intended for mobility, not for diagnosing any medical condition.
No
The device description clearly states it consists of a rigid, mechanical, steel frame, wheels, and upholstery, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "providing mobility to persons limited to a sitting position." This describes a physical aid for movement, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description details a mechanical wheelchair with a frame, wheels, and upholstery. This is consistent with a mobility device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions through in vitro testing.
Therefore, the AXS-1 Lite Wheelchair is a mobility device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
AXS-1 Lite Wheelchairs are indicated for providing I. mobility to persons limited to a sitting position
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Access Point Medical Explorer Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical. steel frame and leatherette or nylon upholstery that meets FN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors, over smooth Transport Series. Transport Chair is and China C standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
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.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
ﺒﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K050279
Trade/Device Name: AXS-1 Lite Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 24,2005 Received: March 24,2005
Dear Dr. Estrin:
This letter corrects our substantially equivalent letter of April 11, 2005 regarding the incorrect trade name listed as Explorer Wheelchair. The correct trade name is listed above.
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.
1
Page 2 - Norman F. Estrin Ph.D., RAC
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.
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 (240) 276-0120. 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/cdrb/industry/support/index.html.
Sincerely yours,
Stypt Rhodes
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
2
Indications for Use
ﻴ
Page 1 of 1
| 51 Ojk) Number (if known): | K050279 |
|---|---|
| ---------------------------- | --------- |
Device Name: AXS-1 Lite Wheelchairs
- Indications for Use: AXS-1 Lite Wheelchairs are indicated for providing I. mobility to persons limited to a sitting position
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C) ✓
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion Sign-Of Division of General, Restorative, and Neurological Devices
0010
510(k) Number K050279
3
Image /page/3/Picture/0 description: The image shows the date APR 1 2005, followed by a logo with a circle and a black arrow pointing upwards. Below the logo, the words ACCESS POINT are written in large, bold letters. Underneath ACCESS POINT, the word MEDICAL is written in smaller letters. There is also a letter K on the right side of the image.
SUMMARY OF SAFETY AND EFFECTIVENESS 3.
A. SPONSOR IDENTIFICATION
Mr. Patrick Richey Access Point Medical, L.L.C. 10 Glenville Street Greenwich. CT 06831
B. ESTABLISHMENT REGISTRATION NUMBER: Pending
OFFICIAL CONTACT PERSON C. Norman F. Estrin, Ph.D., RAC
President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com
Tel: (301) 279 -2899 Fax: (301) 294-0126 .
DATE OF PREPARATION OF THIS SUMMARY: February 4, 2005 D.
- Explorer Wheelchair PROPRIETARY (TRADE) NAME: E.
- Wheelchair COMMON NAME: F.
- CLASSIFICATION NAME: Wheelchair, mechanical G.
- REGULATION NUMBER: 21 CFR 890.3850 H.
- PROPOSED REGULATORY CLASS: Class 1 l.
- DEVICE PRODUCT CODE: IOR .).
- K. MEDICAL SPECIALTY: Physical Medicine
10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet.
4
KO50279 2/2
し. DESCRIPTION OF DEVICE
The Access Point Medical Explorer Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical. steel frame and leatherette or nylon upholstery that meets FN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors, over smooth Transport Series.
Transport Chair is and China C standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
M. INDICATIONS FOR USE
The Explorer Wheelchair is indicated for providing mobility to persons limited to a
sitting position sitting position.
N. PREDICATE DEVICE
Jiangsu Inco Medical Equipment Supply Co, EZ-Traveler 3000 Series Wheelchair (K002670).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
The Explorer Wheelchair and Jee Jiangsu Inco Medical Equipment Supply Co, EZ-Traveler 3000 Series Wheelchair (K002670) are substantially equivalent products in all areas impacting safety and effectiveness.
P. TECHNOLOGICAL CHARACTERISTICS SUMMARY
Access Point Medical wheelchair production meets the following standards:
Wheelchair: Determination of static stability ISO 7171-1
ISO 7176-3 Wheelchair: Determination of efficiency of brakes
Wheelchair: Requirements and test methods for statics impact and ISO 7176-8 fatiguc strengths
ISO 7176-11 Wheelchair: Test dummies
ISO 7176-15 Wheelchair: Requirements for information disclosure, documentation and labeling.
ISO 7176-16 Wheelchair: Resistance of ignition of upholstered parts – Requirements and test methods
EN 1021-1 Furniture – Assessment of the Ignitability of Upholstered Furniture
Q. CONCLUSION
Access Point Medical Explorer Wheelchair conforms fully to the standards which are noted in Section P as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims required by these standards. There are no safety/efficiency issues or claims that differ from the prodicate device cited.