Welch Allyn, Inc.
S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive…
S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive touch control and menu navigation with 2.8 inch antiglare color display , heart rate display when actively communicating with monitoring node , water resistant protection with IPX4 rating , includes rechargeable Lithium ion battery pack with 32 hour typical runtime, single use clip on pouch and user instructions.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan CFE Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Chero Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Hangzhou VivaLNK Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 4 |
Record
| Listed by | Welch Allyn, Inc., United States |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141020 |
| Record published | 2019-09-30 |
| Record revised | 2023-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-06-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 901006 | In distribution | |
| 901138 | In distribution | |
| 901011 | In distribution | |
| 901150 | Withdrawn | |
| 901139 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Sync | Covidien LP | 29 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden Corp. | 22 |
| LifeSync | LifeSync Corporation | 18 |
| Surveyor Patient Cable | Mortara Instrument, Inc. | 18 |
| Isansys | Isansys Lifecare, Ltd. | 15 |
| ZephyrLIFE Home | Zephyr Technology Corporation | 11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden America, Inc. | 9 |
| InTouch Health | Intouch Health, Inc. | 7 |
| UbiqVue | LifeSignals, Inc. | 6 |
| X12+ | Mortara Instrument, Inc. | 5 |
| Ezypro ECG Recorder | Sigknow Biomedical Co., Ltd. | 3 |
| Wi-Box™ | St. Jude Medical | 3 |
Showing 12 of 211. All products under Transmitters And Receivers, Physiological Signal, Radiofrequency
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.