Identity
- Trade Name
- Folding Shower Seat FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- The Fold Down Seat is a high quality, commercial grade, fold down shower seat. The Fold Down Seat is intended to provide shower seating support for people with reduced mobility. The Fold Down Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Fold Down Seat is intended to be folded up when not in use. The hinge allows the seat to open slowly, and lock against the wall in the folded position. The Fold Down Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 440lbs / 200kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Fold Down Seat is not to be used in any other way than described above. FDA UDI
- Model / Reference
- FDS-S FDA UDI
- Description
- The Fold Down Seat is a high quality, commercial grade, fold down shower seat. The Fold Down Seat is intended to provide shower seating support for people with reduced mobility. The Fold Down Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Fold Down Seat is intended to be folded up when not in use. The hinge allows the seat to open slowly, and lock against the wall in the folded position. The Fold Down Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 440lbs / 200kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat). The Fold Down Seat is not to be used in any other way than described above. FDA UDI
Identifiers
- Catalog Number
- 03526 FDA UDI
- Primary DI / UDI-DI
- 00689281035262 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Shower seat, non-powered
Folding Shower Seat by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Healthcraft Products Inc.
Sources (1)
- FDA UDI e777ab69-f6ad-4b66-b491-7b61b1bf1210 34 fields · synced May 30, 2026