FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
K Number: K022696
·
Decision Feb 7, 2003
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
9
Review Days
178
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
- K Number
- K022696
- 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
- February 7, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
Power Wheelchair (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine
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 |
| 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 |