HEEL/ELBOW PROTECTOR
FDA 510(k) clearance K771913 · decided 1977-11-15
Clearance details
- K-number
- K771913
- Device name
- HEEL/ELBOW PROTECTOR
- Applicant
- Alba-Waldensian, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-10-11
- Decision date
- 1977-11-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- FMP
- Device class
- 1
- Regulation number
- 880.6450
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Invictus Medical GelShield (K150243) | Invictus Medical, Inc. | 2015-05-01 |
| COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325) | Richard Hamer Assoc., Inc. | 1995-07-31 |
| MEDSURG STERILE IMAGING PRODUCTS (K934731) | Medsurg Industries, Inc. | 1994-03-28 |
| DECUBICARE PADS & ACCESSORIES (K820584) | Abco Dealers, Inc. | 1982-03-25 |
| HEEL OR ELBOW PROTECTOR (K812344) | Fred Sammons, Inc. | 1981-09-11 |
| SPENCO DERMAL PADS (K811184) | Spenco Medical Corp. | 1981-05-20 |
| SCANLAN VASCU-STATT (K802829) | Scanlan Intl., Inc. | 1981-01-15 |
| ARTERIAL BLOOD SAMPLING KIT (K802185) | Current Technologies, Inc. | 1980-10-10 |
| FLOTATION PAD FOR OPERATING TABLE (K801694) | Action Products, Inc. | 1980-08-27 |
| DERMALEX OR NATRAWOOL SKIN PRESSURE PROT (K801195) | Stock Wild & Co. | 1980-06-09 |
| SPAN AIDS KIT (K792297) | American Hospital Supply Corp. | 1979-12-20 |
| HEEL/ELBOW PROTECTORS (K791709) | Fibre Formations, Inc. | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.