The following data is part of a premarket notification filed by Oriental Inspiration Limited with the FDA for Electrical Neuromuscular Stimulator (cure Trio Mc-130 Ios, Cure Trio Mc-310 Android).
| Device ID | K212285 |
| 510k Number | K212285 |
| Device Name: | Electrical Neuromuscular Stimulator (Cure Trio MC-130 IOS, Cure Trio MC-310 Android) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2021-12-22 |