TENS PRO 900
FDA 510(k) clearance K915663 · decided 1993-04-15
Clearance details
- K-number
- K915663
- Device name
- TENS PRO 900
- Applicant
- Acuhealth (Usa) Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-18
- Decision date
- 1993-04-15
- Days to decision
- 484 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Eugene, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.