ClearChest®
Comfort Band, UL, Medium
1manufacturer
31catalogue numbers in this listing
1510(k) clearance
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 | Respiratory Technologies, Inc., United States |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K051383 |
| Record published | 2016-09-10 |
| Record revised | 2025-09-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 6 |
| Sizes | Circumference 16 to 60 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100152-000 | Circumference 52 in | In distribution |
| 100154-000 | Circumference 54 in | In distribution |
| 100118-000 | Circumference 18 in | In distribution |
| 100108-000 | Small | In distribution |
| 100130-000 | Circumference 30 in | In distribution |
| 100124-000 | Circumference 24 in | In distribution |
| 100140-000 | Circumference 40 in | In distribution |
| 100148-000 | Circumference 48 in | In distribution |
| 100102-000 | Small | In distribution |
| 100105-000 | XLarge | In distribution |
| 100136-000 | Circumference 36 in | In distribution |
| 100110-000 | Large | In distribution |
| 100116-000 | Circumference 16 in | In distribution |
| 100158-000 | Circumference 58 in | In distribution |
| 100142-000 | Circumference 42 in | In distribution |
| 100144-000 | Circumference 44 in | In distribution |
| 100156-000 | Circumference 56 in | In distribution |
| 100134-000 | Circumference 34 in | In distribution |
| 100109-000 | Medium | In distribution |
| 100126-000 | Circumference 26 in | In distribution |
| 100150-000 | Circumference 50 in | In distribution |
| 100111-000 | Xlarge | In distribution |
| 100120-000 | Circumference 20 in | In distribution |
| 100104-000 | Large | In distribution |
| 100132-000 | Circumference 32 in | In distribution |
| 100103-000 | Medium | In distribution |
| 100122-000 | Circumference 22 in | In distribution |
| 100138-000 | Circumference 38 in | In distribution |
| 100160-000 | Circumference 60 in | In distribution |
| 100128-000 | Circumference 28 in | In distribution |
| 100146-000 | Circumference 46 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G5® | General Physiotherapy, Inc. | 354 |
| InCourage® | Respiratory Technologies, Inc. | 252 |
| SmartVest | Electromed, Inc. | 172 |
| The Vest®System | Hill-Rom Services Pte, Ltd. | 97 |
| AffloVest | Tactile Systems Technology Inc | 39 |
| 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 |
|---|---|
| K051383 | 2005-06-17 |
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.