The following data is part of a premarket notification filed by Turbo Wheelchair Co., Inc. with the FDA for Merlexi Craft Series Of Manual (mechanical) Wheelchairs.
| Device ID | K032731 |
| 510k Number | K032731 |
| Device Name: | MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | TURBO WHEELCHAIR CO., INC. 76 MERIDIAN RD. BEAUFORT, SC 29907 |
| Contact | JANE HERMES |
| Correspondent | JANE HERMES TURBO WHEELCHAIR CO., INC. 76 MERIDIAN RD. BEAUFORT, SC 29907 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-03 |
| Decision Date | 2003-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000595407 | K032731 | 000 |