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Data / Medical devices / Percussor, Powered-Electric

Percussor, Powered-Electric (BYI): 28 FDA-registered makers in 10 countries

28 establishments in 10 countries are registered with the FDA to make Percussor, Powered-Electric (product code BYI, Class 2, 21 CFR 868.5665). 17 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on April 30, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
BYI
Device class
2
Regulation
868.5665
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States16
Singapore2
United Kingdom2
Mexico2
Australia1
China1
Israel1
Dominican Republic1
Costa Rica1
Malaysia1

Makers of Percussor, Powered-Electric

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Hill-Rom Manufacturing, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler4March 22, 2024010api.fda.gov
Hill-Rom Services Private LimitedSingapore North East, SingaporeComplaint file establishment, Specification developer4March 22, 2024000api.fda.gov
Electromed, Inc.New Prague, MN, United StatesComplaint file establishment, Manufacturer3November 18, 2022000api.fda.gov
Tactile Systems Technology IncNew Brighton, MN, United StatesManufacturer2April 30, 2026000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1February 20, 1986000api.fda.gov
Better Breathing Devices Pty LtdTweed Heads South New South Wales, AustraliaExporter to the US, Manufacturer1January 15, 2021000api.fda.gov
Clement Clarke Intl., Ltd.Mountain Ash Rhondda Cynon Taff, United KingdomSpecification developer1May 24, 1994000api.fda.gov
Chongqing Sonmol Technology Co., Ltd.Chongqing, ChinaExporter to the US, Manufacturer1December 18, 2024000api.fda.gov
General Physiotherapy Ii LLCSaint Charles, MO, United StatesManufacturer1January 23, 1986000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1August 18, 1981000api.fda.gov
Intersurgical Inc.Indianapolis, IN, United StatesManufacturer1October 23, 1991000api.fda.gov
Med SystemsSan Diego, CA, United StatesManufacturer1November 21, 2003000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer1November 22, 2013000api.fda.gov
Respiratory Technologies, Inc.Plymouth, MN, United StatesComplaint file establishment, Specification developer1June 17, 2005000api.fda.gov
Synchrony Medical LtdOr Yehuda Tel Aviv, IsraelManufacturer1December 19, 2024000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer1February 20, 1986000api.fda.gov
Thayer Medical CorportationTucson, AZ, United StatesManufacturer1August 6, 1998000api.fda.gov
AccuMed Corp.Nigua San Cristobal, Dominican RepublicContract manufacturer0000api.fda.gov
Core Products International IncChetek, WI, United StatesContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomContract manufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesContract manufacturer0000api.fda.gov
Multisource Manufacturing LLCLongmont, CO, United StatesContract manufacturer0000api.fda.gov
Nextern Costa Rica Ltd.Cartago, Costa RicaContract manufacturer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
Smooth-Bor PlasticsLaguna Hills, CA, United StatesContract manufacturer0000api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VMAGDALENA Sonora, MexicoContract manufacturer0000api.fda.gov

Updated April 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.