510(k) K021509
- Device
- HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
- Applicant
- HYGIA HEALTH SERVICES, INC.
- 510(k) number
- K021509
- Product code
- JOW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-24
- Date received
- 2002-05-09
- Regulation
- 870.5800
- Classification name
- Sleeve, Limb, Compressible
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEOFF M FATZINGER
- Address
- 2800 Milan Ct., Suite 259 Birmingham AL US 35211 35211
FDA Registration Numbers#
- 3012341425
- 3004183512
- 3000143502
- 3030517288
- 3027500264
- 3017618673
- 3016000973
- 3011539161
- 3010190204
- 3029905040
- 9616933
- 3005619970
- 3030441550
- 3013528589
- 2183650
- 3005157379
- 3027977504
- 1220908
- 3010148613
- 3007420694
- 3021767551
- 1650907
- 9616086
- 3009176340
- 3011529836
- 3014342658
- 3017264244
- 3018094310
- 1649518
- 3003801933
- 1047843
- 3009538657
- 3004105270
- 3012174974
- 3009211636
- 3011149139
- 9616088
- 3009437400
- 1018470
- 3020163307
- 3011118518
- 3034520
- 3043226252
- 3010256111
- 2027046
- 1834003
- 3007699082
- 2031823
- 2424387
- 3007518069
- 3024685280
- 8043439
- 3012446970
- 3006792041
- 1928237
- 3034205725
- 3013659199
- 3032062344
- 3011191255
- 8043817
- 3033981998
- 1921846
- 3030063003
- 1061927
- 3012494290
- 3004116008
- 1000589001
- 3014947294
- 3014344059
- 1417592
- 1423537
- 3011219270
- 3008773774
- 1450371
- 9611425
- 3008902816
- 3011024991
- 3038295706
- 3029871637
- 3023215120
Source Documents#
Other 510(k) Records For Product Code JOW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026-06-25 |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | 2026-02-24 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | 2025-10-28 |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | 2025-09-17 |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025-08-18 |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | 2025-08-08 |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 |
| K241746 | 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 | United Medical Resources, LLC | 2024-10-04 |
| K232640 | Venowave VW5 | Thermabright | 2024-06-25 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 |
Legacy Summary#
summary
FDA Review#
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