The following data is part of a premarket notification filed by Princeton Electronic Systems, Inc. with the FDA for Pes Hot/cold Compress.
| Device ID | K962038 |
| 510k Number | K962038 |
| Device Name: | PES HOT/COLD COMPRESS |
| Classification | Pad, Heating, Powered |
| Applicant | PRINCETON ELECTRONIC SYSTEMS, INC. 37 STATION DR. Princeton Jct, NJ 08550 |
| Contact | Charles H Seidel, Jr. |
| Correspondent | Charles H Seidel, Jr. PRINCETON ELECTRONIC SYSTEMS, INC. 37 STATION DR. Princeton Jct, NJ 08550 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-24 |
| Decision Date | 1996-11-13 |