PlayMakar Sport Muscle Stimulator, Model PRO-500— 510(k) K182581
Substantially EquivalentPlaymakar, Inc.
FDA 510(k) clearance K182581 for PlayMakar Sport Muscle Stimulator, Model PRO-500, Substantially Equivalent on 2018-11-21. Applicant: Playmakar, Inc.. Device class: 2.
Clearance details
- Applicant
- Playmakar, Inc.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southlake, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.