(49 days)
Not Found
No
The description focuses on the mechanical and structural components of a wheelchair designed for various terrains and water use. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
No
A therapeutic device is one that treats or alleviates a medical condition. This device is a wheelchair, which is a mobility aid designed to assist individuals with limited mobility, but it does not treat or cure any medical condition.
No
The provided text describes a mechanical wheelchair for transport and mobility across various terrains and in water. There is no mention of the device being used to diagnose any medical condition or performing any diagnostic function.
No
The device description explicitly lists multiple physical components (wheelchair frame, pushbar, trunk harness, etc.) and describes it as a mechanical wheelchair, indicating it is a 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 to provide mobility for individuals on various terrains and in water. This is a physical support and mobility device.
- Device Description: The description details a mechanical wheelchair with various components for physical support and movement.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a person's health status, disease, or condition based on sample analysis.
- Any diagnostic purpose.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The Hippocampe Wheelchair does not fit this description.
N/A
Intended Use / Indications for Use
The Hippocampe Wheelchair is a versatile, mechanical, wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
Product codes (comma separated list FDA assigned to the subject device)
IQC
Device Description
The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.
- Wheel chair t
- Pushbar .
- Trunk harness (optional) .
- Armrest (optional) .
- Headrest (optional) .
- . Skiing kit (optional)
- . Traction kit
- Transport bag (optional) .
The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.
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)
Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use.
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
§ 890.3880 Special grade wheelchair.
(a)
Identification. A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.(b)
Classification. Class II (performance standards).
0
AUG 1 5 2005 510(k) Summary
for
Vipamat Technologie Hippocampe Wheelchair
1. SPONSOR
Vipamat Technologie ZA La Vraie Croix 56270 Ploeumer France
Contact Person: Franck Coeudo 33 2 97 86 24 87 Telephone:
Date Prepared: June 23, 2005
2. DEVICE NAME
| Proprietary Name: | Hippocampe Wheelchair |
|---|---|
| Common/Usual Name: | Mechanical Wheelchair |
| Classification Name: | Mechanical Wheelchair |
3. PREDICATE DEVICES
| DB Perks and Associates Stainless Steel Aquatic Chair | K031910 |
|---|---|
| Landeez All-Terrain Sport Chair | K031342 |
4. DEVICE DESCRIPTION
The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.
- Wheel chair t
- Pushbar .
- Trunk harness (optional) .
- Armrest (optional) .
1
- Headrest (optional) .
- . Skiing kit (optional)
- . Traction kit
- Transport bag (optional) .
The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.
INTENDED USE ട.
The Hippocampe Wheelchair is a versatile, mechanical, wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The overall design of the Hippocampe and the predicate wheelchairs are similar in that they are all low to the ground wheelchairs made of rugged metals and flame retardant materials. They are all compatible with various types of water (pool, occans, lakes etc). All of these devices consist of 3 or 4 wheels with a chassis and pushbar. One minor difference is that the Hippocampe Wheelchair is comprised of three wheels whereas the predicate devices have a four wheel configuration. This difference does not affect safety or effectiveness since safety testing (stability testing) has been completed successfully using the Hippocampe. The technological characteristics are similar in that both the proposed and predicate devices are compatible with various terrains and water. Like the small-pool Hippocampe Wheelchair, the DB Perks Chair is intended only for pool water whereas the standard Hippocampe and Landeez Chairs are intended for either pool water or natural water (ocean, lakes, and ponds) and various terrains.
7. PERFORMANCE TESTING
Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vipamat Technologie c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K051709
Trade/Device Name: Hippocampe Wheelchair Regulation Number: 21 CFR 890.3880 Regulation Name: Special grade wheelchair Regulatory Class: II Product Code: IQC Dated: June 23, 2005 Received: June 28, 2005
Dear Ms. McNamara-Cullinane:
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.
3
Page 2- Ms. Mary McNamara-Cullinane, RAC
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) 276-0115. 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,
Muh A. Millers
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Hippocampe Wheelchair
Indications For Use:
The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkus
. 13131 Sign-Off) 7:30% Sign-Oral, Restorative
Wision of General, Restorative 71310n of Sical Devices