FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENS&EMS units (SM9109A, SM9109B)
K Number: K241509
·
Decision Jun 27, 2024
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
216
Applicant Total
1
Review Days
30
Basic Information
- Device Name
- TENS&EMS units (SM9109A, SM9109B)
- K Number
- K241509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Plexus Yoga LLC Dba Chirp
- Date Received
- May 28, 2024
- Decision Date
- June 27, 2024
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
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