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#
- 3003950102
- 3005798905
- 3012302888
- 3004727197
- 3008729899
- 3010222749
- 9680548
- 3001034529
- 1319390
- 3008780388
- 3001570235
- 3009499478
- 3013561145
- 3006169981
- 3003263092
- 3010419931
- 3003591740
- 1220908
- 8030245
- 2081040
- 3017500903
- 3037007069
- 3007184699
- 3021559257
- 1713468
- 3015328411
- 3006537699
- 3008716327
- 3031158
- 8030476
- 3021186226
- 1018233
- 3014736845
- 3004832480
- 3017887928
- 3010421104
- 3008264255
- 3006146787
- 3008507279
- 3029987970
- 2025816
- 3009831876
- 3042156936
- 2082313
- 3015542362
- 3014982318
- 3012421607
- 3020160672
- 3013826848
- 3007134734
- 3015236197
- 3013596024
- 3038613041
- 3015455735
- 8031509
- 3029871637
- 3012725363
- 3015136472
- 9611295
- 3017953405
- 3019388613
- 3022028624
- 3013053058
- 1523530
- 1218950
- 3017207990
- 3019575688
- 3001744144
- 3009001657
- 9610105
- 3008787503
- 3018940143
- 3016170326
- 3027135885
- 3021635975
- 3009155917
- 3012528160
- 3009973336
- 3011912849
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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