The following data is part of a premarket notification filed by Damor America, Inc. with the FDA for Powered Inflatable Tube Massager, Sport-med.
| Device ID | K901022 |
| 510k Number | K901022 |
| Device Name: | POWERED INFLATABLE TUBE MASSAGER, SPORT-MED |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DAMOR AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | M Holstein |
| Correspondent | M Holstein DAMOR AMERICA, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-03-14 |