Imc-Heart Way LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Imc-Heart Way LLC” (first 2003, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 9 | 9 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
- Physical Medicine (10)
Most recent Imc-Heart Way LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063328 | IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) | ITI | 2007-04-27 | 175 |
| K063320 | ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13) | ITI | 2007-02-27 | 117 |
| K063307 | ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R) | ITI | 2007-02-27 | 118 |
| K063203 | ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) | ITI | 2007-02-13 | 113 |
| K063475 | IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS) | ITI | 2007-01-23 | 68 |
| K063474 | ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) | ITI | 2006-12-22 | 36 |
| K052008 | IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 | ITI | 2005-09-16 | 53 |
| K031897 | PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER | INI | 2003-09-23 | 96 |
| K030432 | IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR | ITI | 2003-05-01 | 80 |
| K030427 | HP-3 HD ELECTRIC WHEELCHAIR | ITI | 2003-04-18 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Imc-Heart Way LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Imc-Heart Way LLC?
FDA lists 10 510(k) clearances under the applicant name “Imc-Heart Way LLC” (first 2003, latest 2007), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imc-Heart Way LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imc-Heart Way LLC is 88 days.
Which FDA product codes appear under Imc-Heart Way LLC?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 9); INI (Vehicle, Motorized 3-Wheeled, 1).
Next steps
- See all 10 Imc-Heart Way LLC clearances with predicates and recalls
- Run predicate analysis for product code ITI, Imc-Heart Way LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.