Protector, Skin Pressure
The Skin Pressure Protector is a device used to protect vulnerable areas of skin, particularly bony prominences, from sustained pressure that could lead to pressure ulcers in bedridden or immobile patients. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMP, regulated under 21 CFR 880.6450 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
Basic Information
- Product Code
- FMP
- Device Class
- FDA class 1
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150243 | Invictus Medical GelShield | May 01, 2015 | Substantially Equivalent | Invictus Medical, Inc. |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Jul 31, 1995 | Substantially Equivalent | RICHARD HAMER ASSOC., INC. |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Mar 28, 1994 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K820584 | DECUBICARE PADS & ACCESSORIES | Mar 25, 1982 | Substantially Equivalent | ABCO DEALERS, INC. |
| K812344 | HEEL OR ELBOW PROTECTOR | Sep 11, 1981 | Substantially Equivalent | FRED SAMMONS, INC. |
| K811184 | SPENCO DERMAL PADS | May 20, 1981 | Substantially Equivalent | SPENCO MEDICAL CORP. |
| K802829 | SCANLAN VASCU-STATT | Jan 15, 1981 | Substantially Equivalent | SCANLAN INTL., INC. |
| K802185 | ARTERIAL BLOOD SAMPLING KIT | Oct 10, 1980 | Substantially Equivalent | CURRENT TECHNOLOGIES, INC. |
| K801694 | FLOTATION PAD FOR OPERATING TABLE | Aug 27, 1980 | Substantially Equivalent | ACTION PRODUCTS, INC. |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Jun 09, 1980 | Substantially Equivalent | STOCK WILD & CO. |
| K792297 | SPAN AIDS KIT | Dec 20, 1979 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K791709 | HEEL/ELBOW PROTECTORS | Sep 24, 1979 | Substantially Equivalent | FIBRE FORMATIONS, INC. |
| K790995 | CONTEX | Jun 11, 1979 | Substantially Equivalent | FOAM TEK, INC. |
| K781246 | FOAM COMFORT RINGS | Aug 10, 1978 | Substantially Equivalent | FIBRE FORMATIONS, INC. |
| K780171 | ELBOW PROTECTOR | Feb 06, 1978 | Substantially Equivalent | STAT MEDICAL CORP. |
| K772419 | HEEL OR ELBOW PROTECTOR | Jan 26, 1978 | Substantially Equivalent | FRED SAMMONS, INC. |
| K772060 | PROTECT IV GARD | Dec 20, 1977 | Substantially Equivalent | OMNICON MEDICAL CORP. |
| K771913 | HEEL/ELBOW PROTECTOR | Nov 15, 1977 | Substantially Equivalent | ALBA-WALDENSIAN, INC. |
| K771633 | HEEL PROTECTOR | Sep 12, 1977 | Substantially Equivalent | MEDICAL RESTRAINTS, INC. |
| K771519 | SPECIALIST ARM & LEG PROTECTOR | Aug 26, 1977 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K770635 | PROTECTOR, HEEL & ELBOW | May 23, 1977 | Substantially Equivalent | TECNOL NEW JERSEY WOUND CARE, INC. |
| K761268 | SKIN PRESSURE PROTECTORS | Feb 16, 1977 | Substantially Equivalent | MARK ONE HEALTHCARE PRODUCTS |
| K760870 | HEEL/ELBOW FLOTATION CUSHION | Nov 01, 1976 | Substantially Equivalent | MEDPRO, INC. |
FEI Numbers
This FDA classification entry is associated with 363 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 363 registration numbers. Click on an entry to view related FDA registrations.