FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE COMFORT LIFT
K Number: K801796
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
244
Registration Numbers
244
Same Product Code
4
Applicant Total
1
Review Days
15
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
- THE COMFORT LIFT
- K Number
- K801796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6785
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gettner Enterprises, Inc.
- Date Received
- July 29, 1980
- Decision Date
- August 13, 1980
- Product Code
- FMR
- 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 |
|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMR), ordered by most recent decision date.
SOLOLIFT - PATIENT TRANSFER STRETCHER
FDA 510(k)
FDA Class 1
·General Hospital
TENDERLIFT
FDA 510(k)
FDA Class 1
·General Hospital
SKIL-CARE TURN AND HOLD PAD
FDA 510(k)
FDA Class 1
·General Hospital
PATIENT TURNING AND REPOSITIONING G DEV.
FDA 510(k)
FDA Class 1
·General Hospital