510(k) K113402
- Device
- SOLOHEALTH STATION
- Applicant
- SOLOHEALTH, INC.
- 510(k) number
- K113402
- Product code
- DRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-05-30
- Date received
- 2011-11-17
- Regulation
- 870.2910
- Classification name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- STEPHEN KENDIG
- Address
- 11555 Medlock Bridge, Suite 190 Duluth GA US 30097 30097
FDA Registration Numbers#
- 3010262192
- 3027344406
- 3004128050
- 3016931915
- 3006769302
- 3015489159
- 3020460367
- 1319390
- 3003294644
- 3009001657
- 3010838917
- 3013920399
- 3010381606
- 3010390468
- 3004009431
- 3004101980
- 3031259044
- 3005737664
- 1423537
- 3017075369
- 1832894
- 3004906872
- 1000379039
- 3011654863
- 3006537699
- 3021635975
- 3020115
- 3016826509
- 3006087789
- 3009901017
- 3008365372
- 3001373226
- 3005798905
- 3038620598
- 3003263092
- 3001149827
- 3006950086
- 9610816
- 3021186226
- 9680215
- 3033530347
- 3006113127
- 3004832480
- 9710654
- 3017303999
- 9710602
- 3007384659
- 3013053058
- 1066444
- 3016170326
- 3003591740
- 8020616
- 3034405508
- 3015236197
- 3008264255
- 3003687189
- 3015181391
- 3020160672
- 3011191255
- 8020605
- 3027135885
- 3007420856
- 3012536737
- 3013426279
- 3024512705
- 3037724692
- 3038761440
- 3015109923
- 3012494290
- 3003703880
- 3008975047
- 3017825461
- 9617476
- 3004022358
- 3017894657
- 3003971136
- 3013557562
- 3008787503
- 3014449259
Source Documents#
Other 510(k) Records For Product Code DRG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026-07-09 |
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026-01-22 |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | 2025-10-02 |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 |
| K241101 | BioButton System | Biointellisense, Inc. | 2024-09-26 |
| K240251 | ANNE Chest | Sibel Health, Inc. | 2024-06-03 |
| K223711 | ANNE One | Sibel Health, Inc. | 2023-08-10 |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023-05-15 |
| K223073 | Alio | Alio, Inc. | 2023-03-17 |
| K222398 | Care Team Portal | Vivify Health, Inc. | 2023-02-06 |
| K212957 | BioButton System | Biolntellisense, Inc. | 2022-12-12 |
| K221530 | ANNE Pediatric | Sibel, Inc. | 2022-11-22 |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022-07-15 |
Legacy Summary#
summary
FDA Review#
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