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#
- 2648045
- 3015236197
- 3008729547
- 3008167616
- 3009456923
- 3003589956
- 3012302888
- 3017896172
- 3003193933
- 3013445220
- 3010390468
- 3016674095
- 3043226252
- 3033589330
- 3014541700
- 3009156722
- 3024512705
- 3016170326
- 3003622639
- 3043513123
- 3004727093
- 3013896610
- 3032948391
- 3013679558
- 3009690509
- 9710654
- 2434008
- 3031789039
- 9610816
- 3038620598
- 2025816
- 3005737664
- 3003971136
- 3018008670
- 3013561145
- 3008483389
- 3010405299
- 3008011951
- 3038761440
- 3007603826
- 3015188281
- 3013596024
- 3010082909
- 3003630387
- 3003981912
- 3018783526
- 3009077524
- 3034405508
- 8020616
- 1713468
- 3043047278
- 3009831876
- 3015309643
- 3009560891
- 3013689228
- 3031259044
- 3007420856
- 3012311599
- 3006537699
- 3010968402
- 3009607734
- 3008820594
- 3013783488
- 2183646
- 3006852037
- 3011420269
- 2032112
- 3013545943
- 9680215
- 3021343210
- 9681377
- 1423537
- 1126271
- 3014736845
- 3027510187
- 3010288146
- 3017303999
- 3005877899
- 3009901017
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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