ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
FDA 510(k) clearance K091933 · decided 2010-04-02
Clearance details
- K-number
- K091933
- Device name
- ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
- Applicant
- Inno-Health Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-30
- Decision date
- 2010-04-02
- Days to decision
- 276 days
- Clearance type
- Special
- Product code
- BWK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Taichung, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.