TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS— 510(k) K991397
Substantially EquivalentSein Electronics Co., Ltd.
FDA 510(k) clearance K991397 for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS, Substantially Equivalent on 2000-02-11. Applicant: Sein Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sein Electronics Co., Ltd.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo Grove, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.