510(k) K760575
- Device
- ROCKER-SOLE CAST SANDAL
- Applicant
- RICHARD'S MEDICAL EQUIP., INC.
- 510(k) number
- K760575
- Product code
- IPG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-06
- Date received
- 1976-09-03
- Regulation
- 890.3025
- Classification name
- Shoe, Cast
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3013515242
- 3006943846
- 1422443
- 3015459201
- 3010595915
- 1060680
- 3042871597
- 3004161950
- 8022755
- 3003829642
- 3042251628
- 3016147813
- 3019756084
- 3012026312
- 1054236
- 3003890514
- 8031020
- 3007127364
- 3017633586
- 2183988
- 3014658541
- 3010785927
- 3027500264
- 3015134013
- 3006227741
- 8022890
- 3011191255
- 3007207474
- 1043214
- 3021275665
- 3004905643
- 3012480144
- 3015287620
- 3008146511
- 3021394836
- 1523547
- 9616086
- 3003764610
- 9611956
- 2950684
- 3012281713
- 3013557562
- 1026765
- 3006619688
- 1424774
- 3013180212
- 1417592
- 3010033845
- 3010309201
- 3007109661
- 2028253
- 3017297225
- 3005663580
- 3010694026
- 3006266055
- 3008395114
- 3005037196
- 3003855936
- 3007076137
- 3016444419
- 3006897996
- 3031027442
- 3014982318
- 2530195
- 3003546412
- 3010703418
- 3004605321
- 1122845
- 3003893701
- 3005533873
- 3014747863
- 3017264244
- 2182345
- 3007774549
- 3008247697
- 3033858295
- 3004179819
- 3013657868
- 3015069144
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K024279 | NESS CHILDREN SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 |
| K790652 | TOGUARD | Togard, Inc. | 1979-04-04 |
| K781363 | CAST SHOE | Cutler Biomedical | 1978-08-14 |
| K780617 | EQUALIZER | Ballert Orthopedic Corp. | 1978-04-18 |
| K760578 | BALANCED CAST SOLE | Parke-Davis Co. | 1976-09-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases