IT-727 (Also Known AS IT-610, IT-600 and Dynaphor II
FDA 510(k) K946337 · Skylark Device Co., Ltd.
510(k) numberK946337
Submission
- Device name
- IT-727 (Also Known AS IT-610, IT-600 and Dynaphor II
- Applicant
- Skylark Device Co., Ltd.
Taiwan, R.O.C., TW - Received
- December 29, 1994
- Decision date
- December 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
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| K981449 | SD-956 Ultrasound TherapyIMI · Traditional | 12/11/1998SE |
| K983964 | Batch #6060 Conductive GelGYB · Traditional | 12/09/1998SE |
| K964437 | GB-1002 TENS with MassageGZJ · Traditional | 08/14/1998SE |
| K974585 | IF-727 Interferential StimulatorLIH · Traditional | 03/06/1998SE |
| K964434 | SD-970EMS Electrical Muscular StimulatorIPF · Traditional | 10/09/1997SE |
| K963729 | SD-610M(ALSO Known AS Standard TENS, SD-609M,SD-611M, Glc-I Standard)GZJ · Traditional | 02/13/1997SE |
| K946299 | PGS123 and HVS-123GZJ · Traditional | 06/26/1995SE |
| K934051 | Bio SDP (Aka Saturn SD, Glc-Iii SD & Stat-Sd)GZJ · Traditional | 07/11/1994SE |
Questions and answers
When was IT-727 (Also Known AS IT-610, IT-600 and Dynaphor II cleared by the FDA?
IT-727 (Also Known AS IT-610, IT-600 and Dynaphor II (K946337) received a 510(k) decision of Substantially Equivalent on December 20, 1995, 356 days after the submission was received.
What is the product code of K946337?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.