Who else makes this device?

Name: RespIn
Brand: RespIn

Anesthesiology › TherapeuticPercussor, Powered-Electric

RespIn

RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce…

Registry build 21.09.26

RespIn 11 Bronchial Airway Clearance System is a “Focused Pulse” High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Chongqing.

Chinese manufacturers registered for FDA product code BYI
Manufacturer	City	Province	Registered as	Device types
Chongqing Sonmol Technology Co., Ltd.	Chongqing	Chongqing	Contract manufacturer	9

Record

Regulatory record for RespIn
Listed by	Respinnovation Sas, United States
FDA product code	BYI
Device type	Percussor, Powered-Electric
Device class	Class 2
Regulation	21 CFR 868.5665
510(k)	K121170
Record published	2016-07-25
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for RespIn
Catalogue number	Size	Status
11		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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InCourage®	Respiratory Technologies, Inc.	252
SmartVest	Electromed, Inc.	172
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

Showing 12 of 34. All products under Percussor, Powered-Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K121170	2012-07-13

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.