FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DALTON LIFT CHAIR
K Number: K131909
·
Decision Feb 24, 2014
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
5
Review Days
243
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Basic Information
- Device Name
- DALTON LIFT CHAIR
- K Number
- K131909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dalton Instrument Corp.
- Date Received
- June 26, 2013
- Decision Date
- February 24, 2014
- Product Code
- INO
- 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 |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
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Other Clearances by Dalton Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K101611 | RELAY POWER WHEELCHAIR | Sep 29, 2010 | Substantially Equivalent |
| K101719 | TACAMO MANUAL WHEELCHAIR | Aug 25, 2010 | Substantially Equivalent |
| K904843 | OSCAR(TM) II CAPNOMETER & PULSE OXIMETER | Apr 9, 1991 | Substantially Equivalent |
| K850178 | DALTON FOLDING WHEELCHAIRS | Apr 25, 1985 | Substantially Equivalent |