Protector, Heel & Elbow
FDA 510(k) K770635 · Tecnol New Jersey Wound Care, Inc.
510(k) numberK770635
Submission
- Device name
- Protector, Heel & Elbow
- Applicant
- Tecnol New Jersey Wound Care, Inc.
Hammonton, NJ, US - Received
- April 4, 1977
- Decision date
- May 23, 1977
- 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 |
|---|---|---|
| K913043 | Modification Tecnol Fluidshield Surgical MasksFXX · Traditional | 08/23/1991SE |
| K911891 | Fluidshield(Tm) Cone Classic(Tm) II Surgical MaskFXX · Traditional | 07/12/1991SE |
| K911907 | Fluidshield Cone Classic II Surg Mask W/Splash VisFXX · Traditional | 07/08/1991SE |
| K896193 | Tecnol Lazer(Tm) Surgical MaskFXX · Traditional | 02/27/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | 07/25/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | 06/23/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | 05/30/1989SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | 05/23/1989SE |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | 01/17/1989SN |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | 07/27/1988SE |
Questions and answers
When was Protector, Heel & Elbow cleared by the FDA?
Protector, Heel & Elbow (K770635) received a 510(k) decision of Substantially Equivalent on May 23, 1977, 49 days after the submission was received.
What is the product code of K770635?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.