510(k) K241746
- Device
- UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF
- Applicant
- United Medical Resources, LLC
- 510(k) number
- K241746
- Product code
- JOW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-04
- Date received
- 2024-06-18
- Regulation
- 870.5800
- Classification name
- Sleeve, Limb, Compressible
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chase Williams
- Address
- 270 W 500 N North Salt Lake UT US 84054 84054
FDA Registration Numbers
- 3010190204
- 8043439
- 3012651177
- 3034205725
- 1061124
- 3010256111
- 3009350690
- 3004727093
- 3004183730
- 3007518069
- 3007420694
- 3012292104
- 3040278145
- 3012446970
- 1450371
- 3010246951
- 3009247326
- 1018470
- 3020163307
- 3014344059
- 1000589001
- 3011024991
- 3027977504
- 3008902816
- 3011118518
- 3009437400
- 8022590
- 3017264244
- 3005012805
- 3033511104
- 3013557562
- 3029923680
- 1423537
- 3005157379
- 2424387
- 3023215120
- 3018269548
- 3014947294
- 3016000973
- 9611425
- 3012174974
- 3012341425
- 3014491159
- 3015536408
- 3009176340
- 3021767551
- 1648700
- 3011529836
- 3013528589
- 3009155917
- 3017618673
- 2028253
- 3005619970
- 1649518
- 3032062344
- 3030153385
- 3038295706
- 3008773774
- 1063312
- 3011191255
- 3014579161
- 3034520
- 1417592
- 1928237
- 1061927
- 3031916218
- 3003619590
- 3010308146
- 3007699082
- 3004105270
- 3014834638
- 3011767724
- 3024685280
- 3012494290
- 1921846
- 3011539161
- 3011219270
- 3033981998
- 3029871637
- 8043817
Source Documents
510(k) summary PDF not indicated by FDA
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|---|---|---|---|
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