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#
- 3015181391
- 3003993690
- 1423537
- 3042928308
- 3006636961
- 3022028624
- 3001744144
- 3033482477
- 3006441164
- 3003074886
- 3033530347
- 3007499349
- 3038613041
- 1066270
- 3003703880
- 3010288146
- 3026753375
- 3015997711
- 9681377
- 3015522053
- 3017887928
- 3013596024
- 3013500228
- 9610816
- 9680215
- 3013053058
- 3003829675
- 3015697152
- 3009690509
- 3009673645
- 3015109923
- 3021635975
- 3022147580
- 9617543
- 3008483389
- 3008167616
- 3004832480
- 3009617411
- 3013826848
- 3013426279
- 8030978
- 3008164770
- 1450057
- 3016931915
- 3007413079
- 8010482
- 3021611414
- 3016719957
- 3010838917
- 1422443
- 3018008670
- 3030733800
- 8043510
- 3004415095
- 3005798905
- 1651104
- 3011420269
- 3003971136
- 3012104670
- 3011200896
- 3001149827
- 3010381606
- 3021559257
- 3038598497
- 3004727093
- 3010536822
- 2412762
- 3011353843
- 9617127
- 3032109181
- 3000126629
- 3004145393
- 1066444
- 3015967131
- 1319390
- 3008925277
- 3015455735
- 1713468
- 1054713
Source Documents#
Other 510(k) Records For Product Code DRG #
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|---|---|---|---|
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| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025-06-04 |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | 2025-05-16 |
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| 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 |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022-06-23 |
Legacy Summary#
summary
FDA Review#
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