The following data is part of a premarket notification filed by Medical Design & Manufacturing Corp. with the FDA for Medical Designs, Inc., Spectrum Ii Tens Device.
| Device ID | K902822 |
| 510k Number | K902822 |
| Device Name: | MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Contact | H Southworth |
| Correspondent | H Southworth MEDICAL DESIGN & MANUFACTURING CORP. 929 EASTWIND DR. Westerville, OH 43081 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-12-19 |