FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HT-WEDGE
K Number: K121287
·
Decision Oct 3, 2012
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
20
Applicant Total
2
Review Days
156
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Basic Information
- Device Name
- HT-WEDGE
- K Number
- K121287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5500
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Date Received
- April 30, 2012
- Decision Date
- October 3, 2012
- Product Code
- FNG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNG | Lift, Patient, Ac-Powered | FDA class 2 | General Hospital |
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Other Clearances by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
| K Number | Device Name | ||
|---|---|---|---|
| K102236 | HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P | Nov 18, 2010 | Substantially Equivalent |