Identity
- Trade Name
- SHOWER STOOL FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- The Shower Stool is a high quality, commercial grade shower seat. The Shower Stool is intended to provide seating support for people with reduced mobility. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the bench). FDA UDI
- Model / Reference
- SST-S FDA UDI
- Description
- The Shower Stool is a high quality, commercial grade shower seat. The Shower Stool is intended to provide seating support for people with reduced mobility. The maximum user weight for this product is 300lbs / 136kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the bench). FDA UDI
Identifiers
- Catalog Number
- 03384 FDA UDI
- Primary DI / UDI-DI
- 00689281033848 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
Shower Stool by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Shower seat, non-powered.
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- Bariatric Tub Transfer Bench — Dynarex Corp. · Class I
- DALTON TRANSFER BENCH — Dalton Medical Corp. · Class I
- Bariatric Shower Chair without Back — Dynarex Corp. · Class I
- INSPIRED — Drive Devilbiss Healthcare · Class I
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 9f0c4b3c-854d-4d18-a35c-4645d9b6445b 34 fields · synced Jun 8, 2026