The following data is part of a premarket notification filed by Oriental Inspiration Limited with the FDA for Keffort (mc-100, Mc-100a).
| Device ID | K213133 |
| 510k Number | K213133 |
| Device Name: | Keffort (MC-100, MC-100A) |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Oriental Inspiration Limited Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre, No. 57 Ting Kok Road, Tai Po, New Territories Hong Kong, CN |
| Contact | Francis Ko |
| Correspondent | Francis Ko Oriental Inspiration Limited Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre, No. 57 Ting Kok Road, Tai Po, New Territories Hong Kong, CN |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2022-04-13 |