FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMFORT + LIFT
K Number: K852812
·
Decision Nov 5, 1985
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
111
Review Days
126
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Basic Information
- Device Name
- COMFORT + LIFT
- K Number
- K852812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Invacare Corp.
- Date Received
- July 2, 1985
- Decision Date
- November 5, 1985
- 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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| K022642 | TWLIGHT, MODEL ISP 9600 | Feb 11, 2003 | Substantially Equivalent |
| K023589 | STORM TDX POWER WHEELCHAIR | Nov 19, 2002 | Substantially Equivalent |