FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BIO-STIM KIT
K Number: K050174
·
Decision Sep 7, 2005
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
6
Review Days
225
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Basic Information
- Device Name
- BIO-STIM KIT
- K Number
- K050174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Skylark Device & Systems Co., Ltd.
- Date Received
- January 25, 2005
- Decision Date
- September 7, 2005
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Skylark Device & Systems Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K053007 | SKYLARK URO PROBE | Dec 5, 2005 | Substantially Equivalent |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR | Jun 6, 2005 | Substantially Equivalent |
| K034005 | SDS-4I | Nov 18, 2004 | Substantially Equivalent |
| K002832 | CONDUCTIVE GEL FOR ULTRASOUND | Aug 6, 2001 | Substantially Equivalent |
| K992652 | SD-730 IF-SDS, PERFECT PULSE IF-SDS | Feb 3, 2000 | Substantially Equivalent |