Data / Medical devices / United States / Permobil, Inc.
Permobil, Inc.: FDA-registered device maker in Lebanon, TN, United States, 9 510(k) clearances
Permobil, Inc. is registered with the FDA (registration 1221084) in Lebanon, TN, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 27, 2020. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221084
- Address
- 300 Duke Dr, Lebanon, TN, United States, 37090
- Owner or operator
- PERMOBIL INC (8030931)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 17, 2006
- Registered through
- 2026
- Brand names listed
- BENTLEY, BENTLEY LT-R, BENTLEY LT, ECLIPSE, Explorer Mini, F3 Corpus, F5 Corpus, F5 Corpus VS, FUZE T50N, FUZE JR, FUZE M50, FUZE T50, K300 PS Junior and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Wheelchair | KNN | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Contract manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wheelchair, Standup | IPL | 2 | Manufacturer | 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 27, 2020 | K190682 | Explorer Mini | IPL | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| October 25, 2019 | K191874 | F5 Corpus VS | IPL | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| March 27, 2015 | K143180 | F3 | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| March 25, 2015 | K143014 | F5 | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| April 17, 2013 | K123290 | M300 & M400 | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| March 3, 2011 | K103477 | PERMOBIL M300 / M400 | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| July 29, 2008 | K081964 | K450 POWERED WHEELCHAIR | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| August 4, 2004 | K041219 | ELECTRO | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
| April 30, 1997 | K960951 | PERMOBIL CHAIRMAN L/CS 8 | ITI | Substantially Equivalent | Permobil AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 19, 2025 | 99267 | Class II | Ongoing | M5 Corpus Power Wheelchair REF,120032 | This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances. | accessdata.fda.gov |
| February 29, 2024 | 99315 | Class II | Ongoing | Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3 | This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over | accessdata.fda.gov |
| February 21, 2012 | 61351 | Not yet classified | Terminated | Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device | The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment. | accessdata.fda.gov |
| March 7, 2003 | 25733 | Not yet classified | Terminated | Permobil Chairman 2K powered wheelchair | One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair. | accessdata.fda.gov |
| January 1, 2003 | 25692 | Not yet classified | Terminated | Permobil Chairman 2K powered wheelchair, Model 1280 | Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Wheelchair, Mechanical
- All makers of Wheelchair, Standup
- All makers of Components, Wheelchair
Updated July 24, 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.