The following data is part of a premarket notification filed by Mckenna & Cuneo with the FDA for Manual Massage Roller.
| Device ID | K936312 |
| 510k Number | K936312 |
| Device Name: | MANUAL MASSAGE ROLLER |
| Classification | Massager, Therapeutic, Manual |
| Applicant | MCKENNA & CUNEO 1575 EYE ST. N.W. Washington, DC 20005 |
| Contact | Tracy P Berns |
| Correspondent | Tracy P Berns MCKENNA & CUNEO 1575 EYE ST. N.W. Washington, DC 20005 |
| 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 | 1993-11-26 |
| Decision Date | 1996-01-29 |