FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
KARMA POWER WHEELCHAIR, MODEL KP-25
K Number: K041678
·
Decision Jul 23, 2004
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
5
Review Days
32
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Basic Information
- Device Name
- KARMA POWER WHEELCHAIR, MODEL KP-25
- K Number
- K041678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karma Medical Products Co., Ltd.
- Date Received
- June 21, 2004
- Decision Date
- July 23, 2004
- Product Code
- ITI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Karma Medical Products Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202506 | Karma Powered Wheelchair | Apr 19, 2021 | Substantially Equivalent |
| K062309 | KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 | Oct 10, 2006 | Substantially Equivalent |
| K062311 | KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 | Oct 4, 2006 | Substantially Equivalent |
| K041677 | KARMA SCOOTER, MODEL KS-747.2 | Aug 5, 2004 | Substantially Equivalent |