Steth IO Spot
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C)…
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| Suzhou Melodicare Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Steth IO |
|---|---|
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| 510(k) | K220196 |
| Record published | 2022-07-21 |
| Record revised | 2024-11-25 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 0 to 35 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Littmann® | 3M Company | 29 |
| Adscope® | American Diagnostic Corp. | 14 |
| Littmann® | 3M Company | 13 |
| RNK Products | Rnk Products, Inc. | 10 |
| Tyto Stethoscope | Tyto Care, Ltd. | 5 |
| Steth IO | Steth IO | 4 |
| Heroic Faith | Heroic Faith International Ltd. | 3 |
| Stethophone Pro | Sparrow Acoustics Inc. | 2 |
| AeviceMD | Aevice Health Pte. Ltd. | 2 |
| Eko Core 500 and CAC500 Founder’s Edition bundle | Eko Devices, Inc. | 1 |
| Eko Core 500 and CAC500 Standard bundle | Eko Devices, Inc. | 1 |
| Stethophone | Sparrow Acoustics Inc. | 1 |
Showing 12 of 79. All products under Stethoscope, Electronic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.