(57 days)
Not Found
No
The description details a manual wheelchair with no mention of AI/ML features or related performance metrics.
No
Explanation: While the device provides mobility for individuals with restricted movement, its primary function is assistive rather than therapeutic. It does not actively treat or prevent a medical condition.
No
Explanation: The device is described as a manual wheelchair intended for mobility, not for diagnosing any medical condition.
No
The device description clearly states it is a "Manual Wheelchair" with a "base with four-wheeled with a seat," 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 clearly stated as providing mobility to persons restricted to a seated position. This is a physical function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a manual wheelchair, which is a mobility aid. There is no mention of reagents, analyzers, or any components typically associated with in vitro diagnostics.
- Lack of IVD Indicators: 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 of diseases or conditions
Therefore, the KARMA Manual Wheelchair, Budget 800 is a medical device for mobility, not an in vitro diagnostic device.
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, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device 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, Budget 800 is Foldable Wheelchair meet the applicable performance requirements as specified in ANSVRESNA 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
KCX623//
OCT - 4 2006
August 4, 2006
46 510(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:
Classification Name:
Common or Usual Name:
KARMA Manual Wheelchair, Budget 800 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, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for Back upholstery material is also the same transport and it is foldable easily. resistance-ignitability fabric.
Performance Testing:
The KARMA Manual Wheelchair, Budget 800 is Foldable Wheelchair meet the applicable performance requirements as specified in ANSVRESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
Legally marketed device for substantial equivalence comparison:
WH Convertible Lightweight Wheelchair, WHL100 ( K060251 )
1
Comparison Table_
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| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| BRAND NAME | KARMA | WH |
| MANUFACTURER | KARMA Medical Products | |
| Co., Ltd. | Well Home Health Products Co. | |
| MODEL NO | Budget 800 | WML100 |
| 510K NO | K062311 | K060251 |
| INTENDED USE | SAME | The device is intended for |
| medical purposes to provide | ||
| mobility to persons restricted | ||
| to a sitting position. | ||
| FRAME | ||
| Width | ||
| Cross brace | ||
| Depth | ||
| Seat | ||
| Backrest height | ||
| Reclining backrest | ||
| Seat sling | 610 mm | |
| SAME | ||
| 1080 mm | ||
| width: 407mm / 458 mm | ||
| length: 432mm | ||
| SAME | ||
| SAME | ||
| SAME | 21" (534mm) | |
| YES | ||
| 15.7"(400mm) | ||
| width: 18" (458mm) | ||
| depth: 16" (406mm) | ||
| adjustable | ||
| fixed | ||
| padded nylon | ||
| blue, black | ||
| Frame colors | ||
| ARMREST | ||
| Arm pad | ||
| Flip back | ||
| Height-adjustable | SAME | |
| SAME | Padded | |
| YES, non-detachable | ||
| NO | ||
| HANGERS | ||
| Swing-away | ||
| Elevating leg rest | ||
| Articulating leg rest | ||
| Footplate style | ||
| Heel loop | ||
| Footrest angle | SAME | |
| SAME | ||
| SAME | ||
| Stainless | ||
| SAME | ||
| 30° | NO | |
| NO | ||
| NO | ||
| Nylon fiber(one-piece style) | ||
| NO | ||
| 70° | ||
| REAR AXLE | ||
| Offset axle | SAME | YES |
| YES | ||
| ITEMS | SUBJECT DEVICE | PREDICATE DEVICE |
| MODEL NO | Budget 800 | WML100 |
| REAR WHEEL | ||
| Size | ||
| Tire type | ||
| Handrim material | 24" | convert |
| 12" or 24" | ||
| CASTERS | ||
| Size | ||
| Tire type | 8" | |
| Solid | 7" | |
| Solid | ||
| WHEEL LOCK | SAME | Pull-to-Lock |
| WEIGHT CAPACITY | SAME | 250 lbs / 115 kg |
| WEIGHT OF CHAIR | 14.44 kg or 14.65 kg | 15 kg (33 lb) |
| WARRANTY | 5 years on frame | 6 years on frame |
| OPTIONALACCESSORIES | ||
| Anti-tipper | ||
| Rear stepper | ||
| Fold down push handle | YES | |
| YES | ||
| YES | YES | |
| YES | ||
| YES |
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and the comments of the comments of
ﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ
and the comments of
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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. 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.
D4
4
Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2006
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
Re: K062311
Trade/Device Name: KARMA Manual Wheelchair, Budget 800 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 we nave reviewed your betermined 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 r ou may, mercere, mains of the Act include requirements for annual registration, listing of genoral oonlives provisive, 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 i least be advised that i Dri of issuality over device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any I cacal statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quany of trol 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) This letter will anow you to begin maketing your ufrice as valence of your device to a legally
premarket notification. The FDA finding of substantial equipal this permits vo premarket notification. The I DA Intuing of bassanal on 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
rs the regulation of the 10-10-10-10-10-10-10-10-10-19 regulation entitled If you desire specific advice for your do noo on our of on one note the regulation entitled, the legit contact the Office of Compliance at (240) 210 - 1240 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misbranding by relefence to pic.narket notifiedated.