510(k) K011707 ยท INI Vehicle, Motorized 3-Wheeled
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
| Applicant | Merits Medical Industries Co., Ltd., Cape Coral FL, US |
| Decision | Substantially Equivalent, Aug 3, 2001 |
| Received | Jun 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2021 | Merits Holdings Co. dba Merits Health Products, Inc. Scooter Open, Classified |
INI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.