Product code FMP
- Device name
- Protector, Skin Pressure
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6450
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | 2015-05-01 |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Richard Hamer Assoc., Inc. | 1995-07-31 |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Medsurg Industries, Inc. | 1994-03-28 |
| K820584 | DECUBICARE PADS & ACCESSORIES | Abco Dealers, Inc. | 1982-03-25 |
| K812344 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | 1981-09-11 |
| K811184 | SPENCO DERMAL PADS | Spenco Medical Corp. | 1981-05-20 |
| K802829 | SCANLAN VASCU-STATT | Scanlan Intl., Inc. | 1981-01-15 |
| K802185 | ARTERIAL BLOOD SAMPLING KIT | Current Technologies, Inc. | 1980-10-10 |
| K801694 | FLOTATION PAD FOR OPERATING TABLE | Action Products, Inc. | 1980-08-27 |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Stock Wild & Co. | 1980-06-09 |
| K792297 | SPAN AIDS KIT | American Hospital Supply Corp. | 1979-12-20 |
| K791709 | HEEL/ELBOW PROTECTORS | Fibre Formations, Inc. | 1979-09-24 |
| K790995 | CONTEX | Foam Tek, Inc. | 1979-06-11 |
| K781246 | FOAM COMFORT RINGS | Fibre Formations, Inc. | 1978-08-10 |
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | 1978-02-06 |
| K772419 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | 1978-01-26 |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | 1977-12-20 |
| K771913 | HEEL/ELBOW PROTECTOR | Alba-Waldensian, Inc. | 1977-11-15 |
| K771633 | HEEL PROTECTOR | Medical Restraints, Inc. | 1977-09-12 |
| K771519 | SPECIALIST ARM & LEG PROTECTOR | Johnson & Johnson Professionals, Inc. | 1977-08-26 |
| K770635 | PROTECTOR, HEEL & ELBOW | Tecnol New Jersey Wound Care, Inc. | 1977-05-23 |
| K761268 | SKIN PRESSURE PROTECTORS | Mark One Healthcare Products | 1977-02-16 |
| K760870 | HEEL/ELBOW FLOTATION CUSHION | Medpro, Inc. | 1976-11-01 |
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| G096R929220 | 9Line | Rising Eagle Medical LLC | 2024-01-30 |
| G0648317270013971 | TurnAssist® | POSITION HEALTH, LLC | 2022-12-09 |
| 10190676006516 | POSEY | POSEY PRODUCTS, LLC | 2022-10-06 |
| 10190676006523 | POSEY | POSEY PRODUCTS, LLC | 2022-10-06 |
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| 10603354300023 | WAFFLE | EHOB INC | 2020-08-21 |
| 10603354300016 | WAFFLE | EHOB INC | 2020-08-21 |
| 10603354120508 | Position Perfect | EHOB INC | 2020-08-21 |
| 10603354120478 | ComfortTopES | EHOB INC | 2020-08-21 |
| 10603354120409 | ComfortTopES | EHOB INC | 2020-08-21 |
| 10603354120379 | ComfortTopES | EHOB INC | 2020-08-21 |
| 10603354120287 | ATR+ | EHOB INC | 2020-08-21 |
| 10603354120256 | ATR+ | EHOB INC | 2020-08-21 |
| 07613327278538 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327261271 | SofCare | STRYKER CORPORATION | 2016-09-24 |
| 07613327261257 | SofCare | STRYKER CORPORATION | 2016-09-24 |