SmartVest
Electromed’s SmartVest Clearway-I Air Pulse Generator is the powered component of a high-frequency chest-wall oscillation system designed to promote airway clearance and improve bronchial…
Electromed’s SmartVest Clearway-I Air Pulse Generator is the powered component of a high-frequency chest-wall oscillation system designed to promote airway clearance and improve bronchial drainage. The device is indicated when external chest manipulation is selected to enhance mucus transport.
A programmable air-pulse generator sends rapidly repeating pulses through a single hose to a wearable vest or wrap. The garment transfers the pulses to the chest and torso, creating a repeating squeeze-and-release motion; the filed item is a refurbished Clearway-I generator, not the complete garment-and-hose system.
Listed Item
Electromed SmartVest Clearway-I Air Pulse Generator – Refurbished
Oscillation System
Electromed describes the system as three primary components: the air-pulse generator, connecting hose and vest garment. In its HFCWO mechanism, repeated chest-wall compression and release helps move mucus from smaller airways toward larger airways, where it can be expectorated or suctioned.
1manufacturer
172catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
Record
| Listed by | Electromed, Inc., United States |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K132794 |
| Record published | 2016-06-30 |
| Record revised | 2023-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | 5-pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-VCS-24 | In distribution | |
| LTUSW-25/30 | In distribution | |
| SV-40-AM-GK | In distribution | |
| I-VAX-48 | In distribution | |
| SQL-W-RD | In distribution | |
| MPH-2000 | In distribution | |
| SQL-W | In distribution | |
| SQL-BB | In distribution | |
| SV-MAINT-KIT | In distribution | |
| SV2100-CAN | In distribution | |
| SV-28-CM-BU | In distribution | |
| LTUSW-30/36 | In distribution | |
| SW-30/36-1 | In distribution | |
| SV-48-AX-BK | In distribution | |
| SV-24-CS-YL | In distribution | |
| SV-36-AS-PK | In distribution | |
| SV-36-AS-GK | In distribution | |
| SQL-CAN-I | In distribution | |
| SV-44-AL-BK | In distribution | |
| SV-32-CL-BK | In distribution | |
| SV-40-AM-PK | In distribution | |
| SQL-BL | In distribution | |
| Clearway Demo | In distribution | |
| SV-44-AL | In distribution | |
| SV-24-CS-PP | In distribution | |
| SQL-I | In distribution | |
| SV-44-AL-RD | In distribution | |
| SV-PEDESTAL | In distribution | |
| SV-40-AM | In distribution | |
| SV2100-JPN | In distribution | |
| SQL-W-BL | In distribution | |
| SQL-MEX-I | In distribution | |
| SV-48-AX-RD | In distribution | |
| SQL | In distribution | |
| SV-36-AS-BU | In distribution | |
| SV-20-SS-RD | In distribution | |
| SV-48-AX-BU | In distribution | |
| Clearway Air Pulse Generator | In distribution | |
| SQL-CORD-A | In distribution | |
| SV-28-CM-BK | In distribution | |
| SMARTVEST-OR | In distribution | |
| SV2100-HKG | In distribution | |
| SV-40-AM-YL | In distribution | |
| SQL_R-BB | In distribution | |
| SV-24-CS-PC | In distribution | |
| SV-48-AX-PK | In distribution | |
| SV-32-CL-GK | In distribution | |
| I-VSS-20 | In distribution | |
| SV-28-CM-YL | In distribution | |
| SV2100-CAN-I | In distribution | |
| SQL_R-W-RD | In distribution | |
| SV-24-CS-BU | In distribution | |
| SV-ORING-KIT | In distribution | |
| SV-28-CM-RD | In distribution | |
| SV-36-AS-RD | In distribution | |
| SV-48-AX-PC | In distribution | |
| SV-36-AS-GC | In distribution | |
| SQL-USA-I | In distribution | |
| SV-36-AS-PP | In distribution | |
| SW-MULTI-5 | In distribution | |
| SV-44-AL-YL | In distribution | |
| SW-36/44-1 | In distribution | |
| SV-36-AS | In distribution | |
| SV-44-AL-GK | In distribution | |
| LTUSW-36/44 | In distribution | |
| SV-32-CL-GC | In distribution | |
| SQL-PEDESTAL | In distribution | |
| SV-20-SS-BK | In distribution | |
| SV-32-CL-PP | In distribution | |
| Clearway-IR | In distribution | |
| SV-32-CL-RD | In distribution | |
| SQL-ESP-I | In distribution | |
| SV-24-CS-GC | In distribution | |
| SQL-W-BB | In distribution | |
| SV-PEDESTAL_R | In distribution | |
| SV2100-ZZZ | In distribution | |
| SW-44/54-1 | In distribution | |
| SV-32-CL | In distribution | |
| SQL_R-W-BL | In distribution | |
| SV-EXT | In distribution | |
| SV-28-CM-GK | In distribution | |
| SV-HOSE-SPU | In distribution | |
| SV-20-SS-GC | In distribution | |
| SV2100_R | In distribution | |
| CLEARWAY-PED | In distribution | |
| SV-28-CM | In distribution | |
| SV-40-AM-PC | In distribution | |
| SV2100-ARG | In distribution | |
| SQL-HKG-I | In distribution | |
| SV-40-AM-GC | In distribution | |
| SQL-USA-W | In distribution | |
| SW-25/30-1 | In distribution | |
| I-VAM-40 | In distribution | |
| FOAM-48 | In distribution | |
| SV-44-AL-PK | In distribution | |
| SV-48-AX-YL | In distribution | |
| SV-48-AX-PP | In distribution | |
| SQL-TWN-I | In distribution | |
| SV-44-AL-GC | In distribution | |
| SQL-RD | In distribution | |
| SV-48-AX-GK | In distribution | |
| SV-CORD-US | In distribution | |
| SV-24-CS-PK | In distribution | |
| SQL_R-BL | In distribution | |
| SV2100 | In distribution | |
| SQL-ITA-I | In distribution | |
| SV-28-CM-PC | In distribution | |
| SV-20-SS-YL | In distribution | |
| I-VCM-28 | In distribution | |
| SV-40-AM-BK | In distribution | |
| LTUSW-44/54 | In distribution | |
| SV-24-CS-BK | In distribution | |
| SV-32-CL-PK | In distribution | |
| SV2100-TUR | In distribution | |
| LTUSW-54/66 | In distribution | |
| LTUSW-17/25 | In distribution | |
| I-VCL-32 | In distribution | |
| SV-FILTER-3 | In distribution | |
| SV-20-SS-BU | In distribution | |
| SV-44-AL-PP | In distribution | |
| Clearway Eval | In distribution | |
| I-VAS-36 | In distribution | |
| SQL_R-RD | In distribution | |
| SQL-I_R | In distribution | |
| Clearway-HOR | In distribution | |
| SV-44-AL-PC | In distribution | |
| SV-20-SS-GK | In distribution | |
| SV-40-AM-BU | In distribution | |
| SV-36-AS-YL | In distribution | |
| SV2100-ARE | In distribution | |
| SV-40-AM-PP | In distribution | |
| SQL-FILTER | In distribution | |
| SQL-USA | In distribution | |
| SQL_R | In distribution | |
| Clearway-I Air Pulse Generator | In distribution | |
| SV2100-MEX | In distribution | |
| SV-20-SS-PC | In distribution | |
| SQL_R-W-BB | In distribution | |
| SV-36-AS-BK | In distribution | |
| FOAM-44 | In distribution | |
| SW-15/25-1 | In distribution | |
| SV-40-AM-RD | In distribution | |
| SQL-MAINT | In distribution | |
| SV2100-USA | In distribution | |
| SV-20-SS | In distribution | |
| SW-17/25-1 | In distribution | |
| SV-44-AL-BU | In distribution | |
| SV-28-CM-PK | In distribution | |
| SV2100-I | In distribution | |
| SV2100-TWN | In distribution | |
| SQL-FOOT-KIT | In distribution | |
| SV-32-CL-BU | In distribution | |
| SV-28-CM-GC | In distribution | |
| SV2100-I_R | In distribution | |
| SV-28-CM-PP | In distribution | |
| SV-32-CL-YL | In distribution | |
| I-VAL-44 | In distribution | |
| SQL_R-W | In distribution | |
| SV-36-AS-PC | In distribution | |
| SV-20-SS-PK | In distribution | |
| SV-24-CS-GK | In distribution | |
| SV-24-CS-RD | In distribution | |
| SV-32-CL-PC | In distribution | |
| SQL-DEU-I | In distribution | |
| SV-24-CS | In distribution | |
| SV2100-KOR | In distribution | |
| SV2100-USA-I | In distribution | |
| SV-48-AX | In distribution | |
| SMARTVEST-HS | In distribution | |
| SW-54/66-1 | In distribution | |
| SV-20-SS-PP | In distribution | |
| SV-48-AX-GC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G5® | General Physiotherapy, Inc. | 354 |
| InCourage® | Respiratory Technologies, Inc. | 252 |
| The Vest®System | Hill-Rom Services Pte, Ltd. | 97 |
| AffloVest | Tactile Systems Technology Inc | 39 |
| ClearChest® | Respiratory Technologies, Inc. | 31 |
| AffloVest | Movair, Inc. | 7 |
| Portex | ICU Medical, Inc | 4 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 3 |
| Vibralung® | Westmed, Inc. | 3 |
| Frequencer | Dymedso, Inc. | 3 |
| Vibralung Patient Kit | Westmed, Inc. | 2 |
| Monarch™ System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222496 | 2022-11-18 |
| K132794 | 2013-12-19 |
| K053248 | 2005-12-01 |
| K040367 | 2004-04-07 |
| K982889 | 1999-06-01 |
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.