510(k) K771633
- Device
- HEEL PROTECTOR
- Applicant
- Medical Restraints, Inc.
- 510(k) number
- K771633
- Product code
- FMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-12
- Date received
- 1977-08-26
- Regulation
- 880.6450
- Classification name
- Protector, Skin Pressure
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3026818268
- 9611274
- 2182345
- 3003715548
- 2182318
- 2182825
- 3012329552
- 1061153
- 3004632523
- 3015134079
- 3021244152
- 3006089112
- 3004967086
- 2133465
- 3013641287
- 2032476
- 1833053
- 9616144
- 3031564213
- 3011230048
- 3008247697
- 3008264111
- 1424774
- 3015069144
- 1051550
- 3015384437
- 3015528095
- 3011137372
- 8022890
- 3015231789
- 1055236
- 3006079533
- 3021336182
- 3008008970
- 3013180212
- 3038290502
- 3017410889
- 3010729057
- 2135152
- 3035523371
- 3013957847
- 3009008046
- 3017488851
- 3017264244
- 3007305128
- 2431499
- 9614562
- 3013424071
- 3010060157
- 3006183537
- 1640425
- 1220351
- 3010359088
- 3011336784
- 9616088
- 2531468
- 3017048841
- 3002714597
- 3004526603
- 1054241
- 3004365956
- 3020704423
- 3006026111
- 9616086
- 3011529836
- 3042251628
- 1319639
- 3031595580
- 3002807310
- 3018269545
- 3013846070
- 2321033
- 3033707699
- 3008044484
- 3024761165
- 2085249
- 1043644
- 1057079
- 3005273623
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMP#
| 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 |