FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TEH LIN POWER SCOOTER, MODEL TL-822
K Number: K042012
·
Decision Sep 24, 2004
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
9
Review Days
60
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Basic Information
- Device Name
- TEH LIN POWER SCOOTER, MODEL TL-822
- K Number
- K042012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teh Lin Prosthetic & Orthopaedic, Inc.
- Date Received
- July 26, 2004
- Decision Date
- September 24, 2004
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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Other Clearances by Teh Lin Prosthetic & Orthopaedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051118 | MODEL TL-360 POWER SCOOTER | May 31, 2005 | Substantially Equivalent |
| K051116 | MODEL TL-560 POWER SCOOTER | May 31, 2005 | Substantially Equivalent |
| K042011 | POWER SCOOTER, MODEL TL0821 | Sep 24, 2004 | Substantially Equivalent |
| K042010 | POWER SCOOTER, MODEL TL-688 | Sep 1, 2004 | Substantially Equivalent |
| K041752 | TEH LIN POWERED WHEELCHAIR, MDG-601 | Aug 5, 2004 | Substantially Equivalent |
| K022696 | TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 | Feb 7, 2003 | Substantially Equivalent |
| K022697 | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 | Jan 24, 2003 | Substantially Equivalent |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | Dec 2, 2002 | Substantially Equivalent |