The following data is part of a premarket notification filed by Imc-heartway, Llc with the FDA for Electric Wheelchair, Model Rumba S (hp4).
| Device ID | K063203 |
| 510k Number | K063203 |
| Device Name: | ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) |
| Classification | Wheelchair, Powered |
| Applicant | IMC-HEARTWAY, LLC 6140 MID METRO DRIVE, SUITE 6 Fort Myers, FL 33912 |
| Contact | Michael Chen |
| Correspondent | Michael Chen IMC-HEARTWAY, LLC 6140 MID METRO DRIVE, SUITE 6 Fort Myers, FL 33912 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2007-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871230251 | K063203 | 000 |