The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Porta-puls Muscle Stimulator.
Device ID | K810244 |
510k Number | K810244 |
Device Name: | PORTA-PULS MUSCLE STIMULATOR |
Classification | Vibrator, Therapeutic |
Applicant | GENERAL PHYSIOTHERAPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IRO |
CFR Regulation Number | 890.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-28 |
Decision Date | 1981-02-26 |