MODELS TENS 7000, EMS 7500 AND TWIN STIM— 510(k) K080661
Substantially EquivalentKoalaty Products, Inc.
FDA 510(k) clearance K080661 for MODELS TENS 7000, EMS 7500 AND TWIN STIM, Substantially Equivalent on 2008-03-24. Applicant: Koalaty Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Koalaty Products, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roswell, GA, US
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