The following data is part of a premarket notification filed by Im-able Ltd with the FDA for Able-x.
| Device ID | K120783 |
| 510k Number | K120783 |
| Device Name: | ABLE-X |
| Classification | Exerciser, Non-measuring |
| Applicant | IM-ABLE LTD 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron IM-ABLE LTD 2400 VIA CARILLO Palos Verdes Estates, CA 90274 |
| Product Code | ION |
| CFR Regulation Number | 890.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-06-20 |
| Summary: | summary |