The following data is part of a premarket notification filed by Therapeutic Technologies, Inc. with the FDA for Spectrastim 2000 Muscle Stimulator.
| Device ID | K900029 |
| 510k Number | K900029 |
| Device Name: | SPECTRASTIM 2000 MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | THERAPEUTIC TECHNOLOGIES, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein THERAPEUTIC TECHNOLOGIES, INC. 555 THIRTEENTH ST. NW Washington, DC 20004 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-03 |
| Decision Date | 1990-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B36711000L00 | K900029 | 000 |