FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES
K Number: K002318
·
Decision Oct 11, 2000
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
1
Review Days
72
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Basic Information
- Device Name
- UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES
- K Number
- K002318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- United Chair Mfg., LLC
- Date Received
- July 31, 2000
- Decision Date
- October 11, 2000
- 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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