The following data is part of a premarket notification filed by Tecogics Scientific Ltd. with the FDA for Ex N' Flex Ef-200.
| Device ID | K925270 |
| 510k Number | K925270 |
| Device Name: | EX N' FLEX EF-200 |
| Classification | Exerciser, Powered |
| Applicant | TECOGICS SCIENTIFIC LTD. UNIT 4 72 PRETORIA AVENUE Ottawa, Ontario K1s 1w9, CA |
| Contact | Errol Gray |
| Correspondent | Errol Gray TECOGICS SCIENTIFIC LTD. UNIT 4 72 PRETORIA AVENUE Ottawa, Ontario K1s 1w9, CA |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-19 |
| Decision Date | 1993-07-21 |