(43 days)
Not Found
Not Found
No
The summary describes a manual wheelchair with no mention of AI or ML capabilities.
No.
Explanation: The device is described as a "Manual transportation device" for individuals with walking impediments, propelled by an attendant. It does not provide any therapy or treatment, but rather assists with mobility.
No
Explanation: The device description states "Manual Wheelchair" and its intended use is for "Manual transportation" of individuals unable to walk. This indicates a mobility aid, not a device used to identify, detect, or monitor a medical condition or disease.
No
The device description explicitly states "Manual Wheelchair," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Manual transportation device for person who are unable to walk or have a walking impediment, propulsion by an attendant." This describes a physical aid for mobility, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a "Manual Wheelchair." This is a mechanical device for transportation.
- 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 laboratory testing.
Therefore, this device falls under the category of a medical device for mobility assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.
Product codes
IOR
Device Description
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OTTO Bock
HEALTH CARE
1622924
OCT 1 7 2002
A COMPANY OF THE OTTO BOCK GROUP
North American Parkway N., Suite 100
Two Carlson Parlsway N., Suite 100
Minneapolis, M., S.J., Suite 100
Tollate 203-533-94664
Toull-fee 1-800-328-91464
Bourfree 1-800-328-40
Fax 801-956-2401
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
:一 ・
| A. General Information | | Toll-free 1-800-328-4058
Fax 763-519-6153
Toll-free Fax 1-800-962-2549
www.ottobockus.com |
|-------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Submitter's Name: | Otto Bock Health Care, Inc. | Technical Center
14800 28th Avenue North, Suite 110
Minneapolis, MN 55447-4873
Phone 763-519-9000
Toll-free 1-800-795-8846
Fax 763-519-6151
Toll-free Fax 1-800-810-7994
www.ottobockus.com/services |
| 2. Address: | Two Carlson Parkway N., Suite 100
Minneapolis, MN 55447-4467 | |
| 3. Telephone: | 763-553-9464 | |
| 4. Contact Person: | E.P. (Bert) Harman | Customer Support &
Distribution Center
14630 28th Avenue North
Minneapolis, MN 55447-4821
Phone 763-553-9464
Toll-free 1-800-328-4058
Fax 763-519-6150
Toll-free Fax 1-800-962-2549 |
| 5. Date Prepared: | August 14, 2002 | |
| 6. Registration Number: | 2182293 | |
| :. Device | | Design & Manufacturing Center
3820 Great Lakes Drive
Salt Lake City, UT 84120-7205
Phone 801-956-2400 |
| 1. Name: | Sherpa Mobility System
(Manual Wheelchair) | |
| 2. Trade Name: | Sherpa Mobility System
(Manual Wheelchair) | |
| 3. Common Name: | Manual Wheelchair | |
| 4. Classification Name: | Manual Wheelchair | |
| 5. Product Code: | IOR | |
| 6. Class: | I | |
| 7. Regulation Number: | 890.3850 | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles merging into a single form, resembling a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2002
Otto Bock Healthcare E. P. (Bert) Harman CEO/President 2 Carlson Parkway, North Suite 100 Minneapolis, Minnesota 55447-4467
Re: K022924
Trade/Device Name: Sherpa Mobility System (Manual Wheelchair) Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: August 14, 2002 Received: September 4, 2002
Dear Mr. Harman:
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. Iisting 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.
2
Page 2 - Mr. E. P. (Bert) Harman
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N Milburn
for Celia M. Witten, Ph.D., M.D.
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
3
510(k) Number: To be determined
Sherpa Mobility System (Manual Wheelchair) Device Name:
Indications for Use:
- Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.
: : :
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
OVER-THE-COUNTER USE (optional Form 1-2-96)
Mark N. Millison
(Division Sign-Of Restorative and rous ological De
510(k) Number .