FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TEH LIN JUPITER POWER CHAIR, MODEL TL-320
K Number: K022697
·
Decision Jan 24, 2003
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
9
Review Days
164
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Basic Information
- Device Name
- TEH LIN JUPITER POWER CHAIR, MODEL TL-320
- K Number
- K022697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teh Lin Prosthetic & Orthopaedic, Inc.
- Date Received
- August 13, 2002
- Decision Date
- January 24, 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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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 |
| K042012 | TEH LIN POWER SCOOTER, MODEL TL-822 | 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 |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | Dec 2, 2002 | Substantially Equivalent |