Protector, Skin Pressure
FDA product code FMP · Class I (low risk) · 21 CFR 880.6450 · General Hospital
23510(k) clearances
0PMA approvals
4recalls
GMP exemptexempt from GMP rules
Manufacturers
- Fred Sammons, Inc. 2
- Fibre Formations, Inc. 2
- Foam Tek, Inc. 1
- Invictus Medical, Inc. 1
- Richard Hamer Assoc., Inc. 1
- Medsurg Industries, Inc. 1
- Abco Dealers, Inc. 1
- Spenco Medical Corp. 1
- Scanlan Intl., Inc. 1
- Current Technologies, Inc. 1
- Action Products, Inc. 1
- Stock Wild & Co. 1
- American Hospital Supply Corp. 1
- Medpro, Inc. 1
- Stat Medical Corp. 1
- Omnicon Medical Corp. 1
- Alba-Waldensian, Inc. 1
- Medical Restraints, Inc. 1
- Johnson & Johnson Professionals, Inc. 1
- Tecnol New Jersey Wound Care, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150243 | Invictus Medical GelShieldFMP · Traditional | Invictus Medical, Inc. | 05/01/2015SE |
| K951325 | Comfeel Plus Pressure Relief DressingFMP · Traditional | Richard Hamer Assoc., Inc. | 07/31/1995SE |
| K934731 | Medsurg Sterile Imaging ProductsFMP · Traditional | Medsurg Industries, Inc. | 03/28/1994SE |
| K820584 | Decubicare Pads & AccessoriesFMP · Traditional | Abco Dealers, Inc. | 03/25/1982SE |
| K812344 | Heel or Elbow ProtectorFMP · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K811184 | Spenco Dermal PadsFMP · Traditional | Spenco Medical Corp. | 05/20/1981SE |
| K802829 | Scanlan Vascu-StattFMP · Traditional | Scanlan Intl., Inc. | 01/15/1981SE |
| K802185 | Arterial Blood Sampling KitFMP · Traditional | Current Technologies, Inc. | 10/10/1980SE |
| K801694 | Flotation Pad for Operating TableFMP · Traditional | Action Products, Inc. | 08/27/1980SE |
| K801195 | Dermalex or Natrawool Skin Pressure ProtFMP · Traditional | Stock Wild & Co. | 06/09/1980SE |
| K792297 | Span Aids KitFMP · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
| K791709 | Heel/Elbow ProtectorsFMP · Traditional | Fibre Formations, Inc. | 09/24/1979SE |
| K790995 | ContexFMP · Traditional | Foam Tek, Inc. | 06/11/1979SE |
| K781246 | Foam Comfort RingsFMP · Traditional | Fibre Formations, Inc. | 08/10/1978SE |
| K780171 | Elbow ProtectorFMP · Traditional | Stat Medical Corp. | 02/06/1978SE |
| K772419 | Heel or Elbow ProtectorFMP · Traditional | Fred Sammons, Inc. | 01/26/1978SE |
| K772060 | Protect IV GardFMP · Traditional | Omnicon Medical Corp. | 12/20/1977SE |
| K771913 | Heel/Elbow ProtectorFMP · Traditional | Alba-Waldensian, Inc. | 11/15/1977SE |
| K771633 | Heel ProtectorFMP · Traditional | Medical Restraints, Inc. | 09/12/1977SE |
| K771519 | Specialist Arm & Leg ProtectorFMP · Traditional | Johnson & Johnson Professionals, Inc. | 08/26/1977SE |
| K770635 | Protector, Heel & ElbowFMP · Traditional | Tecnol New Jersey Wound Care, Inc. | 05/23/1977SE |
| K761268 | Skin Pressure ProtectorsFMP · Traditional | Mark One Healthcare Products | 02/16/1977SE |
| K760870 | Heel/Elbow Flotation CushionFMP · Traditional | Medpro, Inc. | 11/01/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2640-2020 Class II | Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is…QC inspection observed that a portion of the lot may have been contaminated with blood. | EHOB, Inc. | 06/09/2020Terminated |
| Z-0601-2016 Class II | 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF…Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose… | 3M Company - Health Care Business | 12/01/2015Terminated |
| Z-0206-2015 Class I | Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2…Mold on gel filled Gel-E and Squishon products | Philips Medical Systems, Inc. | 10/10/2014Terminated |
| Z-2192-2014 Class I | Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support…The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold.… | Childrens Medical Ventures | 05/28/2014Terminated |