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Device Explorer · FDA GUDID · GMDN 38122

Chest-oscillation airway secretion-clearing system vest

A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) tre

US‑registered devices410in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Respiratory Technologies, Inc.27467%
Electromed, Inc.13533%
Hill-Rom Services Pte. Ltd.10%

Top labelers

CompanyDevicesShare
Respiratory Technologies, Inc.27467%
Electromed, Inc.13533%
Hill-Rom Services Pte. Ltd.10%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Monarch™ SysteminCourage®InCourage®ClearChest®SmartVest

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
BYIPercussor, Powered-Electric409
BYIPERCUSSOR, POWERED-ELECTRIC1
IZISystem, x-ray, angiographic1
OWBInterventional fluoroscopic x-ray system1
JAASystem, x-ray, fluoroscopic, image-intensified1

GMDN & GCC registration

  • GMDN code 38122 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Circumference (Inch) · 230

Use these as the dimensions to specify in a tender line.

How many chest-oscillation airway secretion-clearing system vest products are registered in the US?

410 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Chest-oscillation airway secretion-clearing system vest", from 3 companies. The largest labeler is Respiratory Technologies, Inc. with 67% of records.

Which FDA product codes apply?

BYI (Percussor, Powered-Electric), BYI (PERCUSSOR, POWERED-ELECTRIC), IZI (System, x-ray, angiographic), OWB (Interventional fluoroscopic x-ray system)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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