The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Hand Massaging Pump (hmp).
| Device ID | K860632 |
| 510k Number | K860632 |
| Device Name: | EBI HAND MASSAGING PUMP (HMP) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | ELECTRO-BIOLOGY, INC. 300 FAIRFIELD RD. Fairfield, NJ 07006 -0293 |
| Contact | Anthony C Parkes |
| Correspondent | Anthony C Parkes ELECTRO-BIOLOGY, INC. 300 FAIRFIELD RD. Fairfield, NJ 07006 -0293 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-20 |
| Decision Date | 1986-04-18 |