The following data is part of a premarket notification filed by Arocep Enterprises Ltd. with the FDA for Stress Handler.
| Device ID | K936148 |
| 510k Number | K936148 |
| Device Name: | STRESS HANDLER |
| Classification | Massager, Therapeutic, Manual |
| Applicant | AROCEP ENTERPRISES LTD. 80 ENGLISH ST. Brampton, Ontario, CA L6x 2p6 |
| Contact | C. G. Pecora |
| Correspondent | C. G. Pecora AROCEP ENTERPRISES LTD. 80 ENGLISH ST. Brampton, Ontario, CA L6x 2p6 |
| Product Code | LYG |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-04-21 |