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
| Country | Makers |
|---|---|
| United States | 16 |
| Singapore | 2 |
| United Kingdom | 2 |
| Mexico | 2 |
| Australia | 1 |
| China | 1 |
| Israel | 1 |
| Dominican Republic | 1 |
| Costa Rica | 1 |
| Malaysia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hill-Rom Manufacturing, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler | 4 | March 22, 2024 | 0 | 1 | 0 | api.fda.gov |
| Hill-Rom Services Private Limited | Singapore North East, Singapore | Complaint file establishment, Specification developer | 4 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Electromed, Inc. | New Prague, MN, United States | Complaint file establishment, Manufacturer | 3 | November 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tactile Systems Technology Inc | New Brighton, MN, United States | Manufacturer | 2 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Specification developer | 1 | February 20, 1986 | 0 | 0 | 0 | api.fda.gov |
| Better Breathing Devices Pty Ltd | Tweed Heads South New South Wales, Australia | Exporter to the US, Manufacturer | 1 | January 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Clement Clarke Intl., Ltd. | Mountain Ash Rhondda Cynon Taff, United Kingdom | Specification developer | 1 | May 24, 1994 | 0 | 0 | 0 | api.fda.gov |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing, China | Exporter to the US, Manufacturer | 1 | December 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| General Physiotherapy Ii LLC | Saint Charles, MO, United States | Manufacturer | 1 | January 23, 1986 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | August 18, 1981 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Manufacturer | 1 | October 23, 1991 | 0 | 0 | 0 | api.fda.gov |
| Med Systems | San Diego, CA, United States | Manufacturer | 1 | November 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | November 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| Respiratory Technologies, Inc. | Plymouth, MN, United States | Complaint file establishment, Specification developer | 1 | June 17, 2005 | 0 | 0 | 0 | api.fda.gov |
| Synchrony Medical Ltd | Or Yehuda Tel Aviv, Israel | Manufacturer | 1 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 1 | February 20, 1986 | 0 | 0 | 0 | api.fda.gov |
| Thayer Medical Corportation | Tucson, AZ, United States | Manufacturer | 1 | August 6, 1998 | 0 | 0 | 0 | api.fda.gov |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing (Singapore) Pte Ltd | SINGAPORE South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multisource Manufacturing LLC | Longmont, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern Costa Rica Ltd. | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smooth-Bor Plastics | Laguna Hills, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welch Allyn De Mexico, S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | MAGDALENA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.