Support, Patient Position
The Patient Position Support is an anesthesiology device used to stabilize and maintain a patient in the required position during surgical or anesthetic procedures, reducing the risk of positional injury and ensuring consistent anatomical alignment throughout the procedure. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCX, regulated under 21 CFR 868.6820, within the Anesthesiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CCX
- Device Class
- FDA class 1
- Regulation Number
- 868.6820
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K943837 | CHIN UP | Oct 14, 1994 | Substantially Equivalent | Edward Carden |
| K932305 | VILA-COOKE(TM) ANESTHESIA PILLOW | Oct 05, 1993 | Substantially Equivalent | Sharn, Inc. |
| K934235 | SNIFF POSITION PILLOW | Oct 01, 1993 | Substantially Equivalent | American Medical Development, Inc. |
| K861915 | SURGICAL HEAD SUPPORT | May 30, 1986 | Substantially Equivalent | Treace Medical, Inc. |
| K833022 | AIR UTERINE DISPLACER-AUD 120 | Oct 14, 1983 | Substantially Equivalent | Scientific Sales Intl., Inc. |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | Jul 20, 1982 | Substantially Equivalent | Body Therapeutics, Inc. |
| K810035 | PRENATAL SUPPORT PILLOW | Jan 23, 1981 | Substantially Equivalent | Supportech, Inc. |
| K801330 | ANSPACH LEG SUPPORT | Jun 26, 1980 | Substantially Equivalent | The Anspach Effort, Inc. |
FEI Numbers
This FDA classification entry is associated with 279 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 280 registration numbers. Click on an entry to view related FDA registrations.