510(k) K992545 ยท ITH Equipment, Traction, Powered
TM-300 TRACTION SYSTEM
| Applicant | Ito Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Sep 1, 1999 |
| Received | Jul 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2005 | Sammons Preston Rolyan, An Ability One Company TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., Terminated |
HST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.