The following data is part of a premarket notification filed by Truro's Ent. with the FDA for Bodyflex Massager.
| Device ID | K952041 |
| 510k Number | K952041 |
| Device Name: | BODYFLEX MASSAGER |
| Classification | Massager, Therapeutic, Electric |
| Applicant | TRURO'S ENT. 760 DALGLIESH DR. Egina, Saskatchewan, CA S4r 6g2 |
| Contact | Derek Parnell |
| Correspondent | Derek Parnell TRURO'S ENT. 760 DALGLIESH DR. Egina, Saskatchewan, CA S4r 6g2 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-08-14 |