510(k) K770223
- Device
- HEAVY FOAM HEEL & ELBOW PROTECTORS
- Applicant
- Robert R. Moore
- 510(k) number
- K770223
- Product code
- IPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-23
- Date received
- 1977-02-03
- Regulation
- 890.3025
- Classification name
- Cover, Limb
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1000357070
- 3024891479
- 3014368824
- 9680835
- 2545
- 1058152
- 8010822
- 3006532285
- 1522166
- 3004464325
- 3007392395
- 1922710
- 3021394836
- 1063312
- 3005037196
- 2028253
- 3016172261
- 3007914557
- 1054236
- 1225916
- 3017633586
- 1824252
- 3006227741
- 3010452421
- 1314417
- 8030901
- 3014747863
- 3017697481
- 3017958535
- 3006008854
- 3007543825
- 3030541652
- 1926174
- 3003827835
- 9615149
- 3006943846
- 3009285151
- 1424263
- 1928237
- 3005276041
- 3005841961
- 3004905643
- 3030413824
- 3004605321
- 1061124
- 3005621301
- 3045857302
- 3004824601
- 3009068676
- 3014108257
- 3015414875
- 9710020
- 3029975230
- 2031918
- 3018070833
- 2242474
- 3007076137
- 1030451
- 3004111573
- 3008016588
- 3018762595
- 3003849847
- 3014658541
- 3009417901
- 3010033845
- 3027500264
- 3021581046
- 3005621808
- 3015146876
- 3010595915
- 3004161950
- 1061153
- 3045816907
- 2029275
- 3005190268
- 3005012805
- 3010508273
- 9616086
- 3016904853
- 3005282622
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Southwest Technologies, Inc. | 1987-09-21 |
| K823399 | COVER LIMB | Orthopedic Systems, Inc. | 1982-11-29 |
| K801627 | COVER, LIMB | The Owenby Co. | 1980-07-28 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | 1978-08-14 |
| K761114 | FOAM SLIPPERS | Fred Sammons, Inc. | 1976-12-02 |