Heel or Elbow Protector
FDA 510(k) K772419 · Fred Sammons, Inc.
510(k) numberK772419
Submission
- Device name
- Heel or Elbow Protector
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 27, 1977
- Decision date
- January 26, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMP – Protector, Skin Pressure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6450
- Specialty
- General Hospital
Other 510(k)s with product code FMP
| 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 |
More from Stock Wild & Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Heel or Elbow Protector cleared by the FDA?
Heel or Elbow Protector (K772419) received a 510(k) decision of Substantially Equivalent on January 26, 1978, 30 days after the submission was received.
What is the product code of K772419?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.