XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
FDA 510(k) clearance K971592 · decided 1998-02-26
Clearance details
- K-number
- K971592
- Device name
- XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
- Applicant
- The Silcraft Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-01
- Decision date
- 1998-02-26
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- ILJ
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| HYDROTONE-THERMAL CAPSULE SYSTEM (K991184) | Nats Corp. | 1999-06-23 |
| VICHY SHOWER (K980909) | Bouvier Hydro, Inc. | 1998-08-11 |
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Recalls involving this device
No recalls on record reference this clearance.