The following data is part of a premarket notification filed by Fairform Mfg., Co., Ltd. with the FDA for Fo41 Body Massager.
| Device ID | K914705 |
| 510k Number | K914705 |
| Device Name: | FO41 BODY MASSAGER |
| Classification | Vibrator, Therapeutic |
| Applicant | FAIRFORM MFG., CO., LTD. 5/F SHING KING INDL. BLDG. 206-208 CHOI HUNG RD. San Po Kong, Kowloon, HK |
| Contact | Wong |
| Correspondent | Wong FAIRFORM MFG., CO., LTD. 5/F SHING KING INDL. BLDG. 206-208 CHOI HUNG RD. San Po Kong, Kowloon, HK |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1991-12-09 |