The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Thermal Therapy System.
| Device ID | K963261 |
| 510k Number | K963261 |
| Device Name: | EBI THERMAL THERAPY SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Sharon A Starowicz |
| Correspondent | Sharon A Starowicz ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1996-09-27 |
| Summary: | summary |