FMP · Protector, Skin Pressure
General Hospital · 21 CFR 880.6450 · Class 1
Overview
| Product Code | FMP |
|---|---|
| Device Name | Protector, Skin Pressure |
| Regulation | 21 CFR 880.6450 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | May 1, 2015 | SESE |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Richard Hamer Assoc., Inc. | Jul 31, 1995 | SESE |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Medsurg Industries, Inc. | Mar 28, 1994 | SESE |
| K820584 | DECUBICARE PADS & ACCESSORIES | Abco Dealers, Inc. | Mar 25, 1982 | SESE |
| K812344 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | Sep 11, 1981 | SESE |
| K811184 | SPENCO DERMAL PADS | Spenco Medical Corp. | May 20, 1981 | SESE |
| K802829 | SCANLAN VASCU-STATT | Scanlan Intl., Inc. | Jan 15, 1981 | SESE |
| K802185 | ARTERIAL BLOOD SAMPLING KIT | Current Technologies, Inc. | Oct 10, 1980 | SESE |
| K801694 | FLOTATION PAD FOR OPERATING TABLE | Action Products, Inc. | Aug 27, 1980 | SESE |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Stock Wild & Co. | Jun 9, 1980 | SESE |
| K792297 | SPAN AIDS KIT | American Hospital Supply Corp. | Dec 20, 1979 | SESE |
| K791709 | HEEL/ELBOW PROTECTORS | Fibre Formations, Inc. | Sep 24, 1979 | SESE |
| K790995 | CONTEX | Foam Tek, Inc. | Jun 11, 1979 | SESE |
| K781246 | FOAM COMFORT RINGS | Fibre Formations, Inc. | Aug 10, 1978 | SESE |
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | Feb 6, 1978 | SESE |
| K772419 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | Jan 26, 1978 | SESE |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | Dec 20, 1977 | SESE |
| K771913 | HEEL/ELBOW PROTECTOR | Alba-Waldensian, Inc. | Nov 15, 1977 | SESE |
| K771633 | HEEL PROTECTOR | Medical Restraints, Inc. | Sep 12, 1977 | SESE |
| K771519 | SPECIALIST ARM & LEG PROTECTOR | Johnson & Johnson Professionals, Inc. | Aug 26, 1977 | SESE |
Top Applicants
- Fibre Formations, Inc. — 2 clearances
- Fred Sammons, Inc. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Action Products, Inc. — 1 clearance
- Alba-Waldensian, Inc. — 1 clearance
