PORTABLE SHOWER BATH
FDA 510(k) clearance K823327 · decided 1982-12-07
Clearance details
- K-number
- K823327
- Device name
- PORTABLE SHOWER BATH
- Applicant
- Wall Manufacturer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-08
- Decision date
- 1982-12-07
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- ILM
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BANKS HYDRO-THERAPY CHAIR (K953796) | Keith Products, Inc. | 1996-04-01 |
Recalls involving this device
No recalls on record reference this clearance.