FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K Number: K033206
·
Decision Dec 18, 2003
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
11
Review Days
77
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Basic Information
- Device Name
- EPW FOLDABLE POWER WHEELCHAIR, EPW-03
- K Number
- K033206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Emg Technology Co., Ltd.
- Date Received
- October 2, 2003
- Decision Date
- December 18, 2003
- 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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|---|---|---|---|
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| K063448 | EMG AC/DC SUCTION UNIT | Nov 30, 2006 | Substantially Equivalent |
| K062888 | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 | Oct 24, 2006 | Substantially Equivalent |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | Jan 31, 2006 | Substantially Equivalent |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | Oct 21, 2005 | Substantially Equivalent |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | Jul 6, 2005 | Substantially Equivalent |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | Dec 16, 2004 | Substantially Equivalent |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | Nov 12, 2003 | Substantially Equivalent |
| K023148 | EPW POWERED WHEELCHAIR, GP-201 | Jan 24, 2003 | Substantially Equivalent |