Data / Medical devices / United States / Michigan Instruments
Michigan Instruments: FDA-registered device maker in Grand Rapids, MI, United States, 2 510(k) clearances
Michigan Instruments is registered with the FDA (registration 1821850) in Grand Rapids, MI, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 14, 2008. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1821850
- Address
- 4717 Talon Ct SE, Grand Rapids, MI, United States, 49512
- Owner or operator
- Michigan Instruments (10058057)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- July 2, 2018
- Registered through
- 2026
- Brand names listed
- Life-Stat Model 1008MII, Thumper Model 1007CC, Thumper Model 1007CCMII, Thumper Model 1007CCV, Thumper Model 1007SC, Thumper Model 1007SCV, Thumper Model 1008, Thumper Model 1008G
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Compressor, Cardiac, External | DRM | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2008 | K073079 | THUMPER, MODEL: 1008 | DRM | Substantially Equivalent | Michigan Instruments, Inc. | accessdata.fda.gov |
| October 2, 1997 | K972525 | THUMPER | DRM | Substantially Equivalent | Michigan Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 13, 2018 | 79764 | Class III | Terminated | Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death | A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last to revolution of the knob could deliver a full 8cm of compression. | accessdata.fda.gov |
| September 14, 2006 | 36313 | Not yet classified | Terminated | Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000. | Failure to initiate compressions when turned on. | accessdata.fda.gov |
| August 4, 2006 | 35934 | Not yet classified | Terminated | Michigan Instruments Thumper Mechanical CPR Device; Model 1007. | Failure to initiate compressions when first turned on, if improperly shut down-Operator Manual updated to include proper shut down procedures | accessdata.fda.gov |
Compare with other makers
Updated February 14, 2008. 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.