Table, Operating-Room, Mechanical
A mechanical operating room table is a manually operated patient positioning platform used during surgical procedures, with height and tilt adjustments made through mechanical mechanisms without electrical power. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FWX, regulated under 21 CFR 878.4950, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FWX
- Device Class
- FDA class 1
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884019 | ALM OPERATING TABLES | Oct 13, 1988 | Substantially Equivalent | Alm Surgical Equipment, Inc. |
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | May 09, 1984 | Substantially Equivalent | Surgi-Quip Inc.U |
| K821923 | TABLE, OPERATING, FIELD 6530-00-709-8175 | Jul 13, 1982 | Substantially Equivalent | Emerson-Sack-Warner Corp. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.