BTL-094
FDA 510(k) clearance K221865 · decided 2023-04-14
Clearance details
- K-number
- K221865
- Device name
- BTL-094
- Applicant
- BTL Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-27
- Decision date
- 2023-04-14
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- ISA
- Device class
- 1
- Regulation number
- 890.5660
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.