(63 days)
Not Found
No
The description details a manual wheelchair and its physical characteristics, with no mention of AI, ML, or any computational processing beyond basic mechanical function.
No
The device is a manual wheelchair intended to provide mobility, which is restorative and not a therapeutic function.
No.
The device is a manual wheelchair intended for mobility, not for diagnosing medical conditions.
No
The device description clearly states it is a "base with four-wheeled with a seat" and is a physical wheelchair, 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 "to provide mobility to persons restricted to a seated position." This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a manual wheelchair with wheels, a seat, and features for transport and folding. This aligns with a mobility aid, not a diagnostic device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a mobility aid designed to assist individuals with physical limitations.
N/A
Intended Use / Indications for Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
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)
The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
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
Ka62309
Image /page/0/Picture/1 description: The image shows the logo for Karma Mobility. The word "KARMA" is in large, bold, sans-serif font. The letter "M" is stylized with a heart shape. Above the heart is a small wing. Below the word "KARMA" is the word "mobility" in a smaller, sans-serif font.
KARMA MEDICAL PRODUCTS CO., LTD.
No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL:886-5-206-6688 FAX : 886-5-206-7788 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw
OC7 1 0 2006
August 5, 2006
66 510(k) SUMMARY "
Submitter's Name: KARMA Medical Products Co., Ltd.
No. 2363, Sec.2, Da-Shiue Road, Min-Hsiung Shiang, Chia-Yi Hsien, 62144, Taiwan, R.O.C.
Date summary prepared:
Device Name:
Proprietary Name:
Common or Usual Name: Classification Name:
KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 Mechanical Wheelchair Mechanical Wheelchair, Class I. 21 CFR 890.3850
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
Performance Testing:
The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
WH Convertible Lightweight Wheelchair, WHL100 ( K060251 )
1
Image /page/1/Picture/0 description: The image shows the logo for Karma Mobility. The word "KARMA" is in large, bold, sans-serif font, with a heart shape above the "M". A wing-like design is above the heart. Below "KARMA" is the word "mobility" in a smaller, sans-serif font.
KARMA MEDICAL PRODUCTS CO., LTD. No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL:886-5-206-6688 FAX:886-5-206-7788 E-mail:eukarma@ms29.hinet.net
http://www.karmamedical.com.tw
Comparison Table
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| BRAND NAME | KARMA | WH |
| MANUFACTURER | KARMA Medical Products | |
| Co., Ltd. | Well Home Health Products Co | |
| MODEL No. | S-Ergo 305 | WML100 |
| 510K No. | K062309 | K060251 |
| INTENDED USE | SAME | The device is intended for |
| medical purposes to provide | ||
| mobility to persons restricted | ||
| to a sitting position. | ||
| FRAME | ||
| Width | 630 mm | 21" (534mm) |
| Cross brace | SAME | YES |
| Depth | 990 mm | 15.7"(400mm) |
| Seat | width: 457mm | |
| length: 432mm | width: 18" (458mm) | |
| depth: 16" (406mm) | ||
| Backrest height | SAME | adjustable |
| Reclining backrest | SAME | fixed |
| Seat sling | SAME | padded nylon |
| Frame colors | SAME | blue, black |
| ARMREST | ||
| Arm pad | Padded, adjustable | Padded |
| Flip back | YES, detachable | YES, non-detachable |
| Height-adjustable | adjustable | NO |
| HANGERS | ||
| Swing-away | SAME | NO |
| Elevating leg rest | SAME | NO |
| Articulating leg rest | SAME | NO |
| Footplate style | Stainless, adjustable | Nylon fiber(one-piece style) |
| Heel loop | SAME | NO |
| Footrest angle | 30° | 70° |
| REAR AXLE | ||
| Offset axle | SAME | YES |
| ITEMS | SUBJECT DEVICE | SUBJECT DEVICE |
| MODEL No. | S-Ergo 305 | S-Ergo105 |
| FOOTPLATE STYLE | Stainless, adjustable | Stainless, fixed |
| ARMREST | Padded, adjustable | Padded, fixed |
| SEAT HEIGHT | Adjustable | Fixed |
2
Image /page/2/Picture/0 description: The image shows the logo for Karma Mobility. The word "KARMA" is written in large, bold, black letters. Above the "M" is a heart with a wing coming out of the top right. Below the word "KARMA" is the word "mobility" in a smaller, less bold font.
KARMA MEDICAL PRODUCTS CO., LTD.
No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. FAX:886-5-206-7788 TEL:886-5-206-6688 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw
SUBJECT DEVICE PREDICATE DEVICE ITEMS MODEL No. S-Ergo 305 WML100 REAR WHEEL convert Size 24" 12" or 24" Tire type Handrim material CASTERS 8" 7" Size Solid Solid Tire type WHEEL LOCK SAME Pull-to-Lock 250 lbs / 115 kg SAME WEIGHT CAPACITY 15 kg (33 lb) 12.9 kg WEIGHT OF CHAIR 6 years on frame 5 years on frame WARRANTY OPTIONALACCESSORIES YES YES Anti-tipper YES Rear stepper YES Fold down push handle YES YES r l
Note: the subject device S-Ergo105 is same as S-Ergo 305 the difference as below:
3
Image /page/3/Picture/0 description: The image shows the word "KARMA" in large, bold, sans-serif font. Above the letter "M" is a heart shape with a wing extending from the right side. Below the word "KARMA" is the word "mobility" in a smaller, sans-serif font. The image appears to be a logo or brand name.
KARMA MEDICAL PRODUCTS CO., LTD. No.2363, Sec.2, Da-Shiue Rd., Min-Hsiung Shiang, Chia-Yi Hsien 62144, Taiwan, R.O.C. TEL : 886-5-206-6688 FAX:886-5-206-7788 E-mail:eukarma@ms29.hinet.net http://www.karmamedical.com.tw
Summary for substantial equivalence comparison:
The intended use of the two devices is the same, and mainframes of two devices are the same foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. Especially, the subject device S-Ergo 305 has the adjustable armrest and footplate. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
The weight limit of the subject device and the predicate device are also 115 kgs, The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs are The light and portable weight of the new device is similar to the predicate same. device and the user can feel more convenient transport it. At last the optional accessories for the two devices are same, and the users have the same status to choose the needed accessories to accommodate their needs.
Thus the new device is substantially equivalent to the predicate devices in this aspect.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karma Medical Products Co., Ltd. % Dr. Jen Ke-Min No. 2363, Sec.2, Da-Shiue Road Min-Hsiung Shiang Chia-Yi Hsien 62144, Taiwan, R.O.C
OCT 1 0 2006
Re: K062309
Trade/Device Name: KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 23, 2006 Received: September 27, 2006
Dear Dr. Ke-Min:
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.
5
Page 2 -- Dr. Jen Ke-Min
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
barbare Buelms
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
Device Name: KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K06 2309 |